Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy

An observational study of Breast Cancer, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line treatment in the US community oncology setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
How many people: 242 participants
Where: 1 siteUnited States
Study dates: 30 Jun 2020to 31 Dec 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated palbociclib combination therapy with AI as the first-line therapy on or after 03 February 2015 up to and including 31 July 2019.

Who may be able to join

Female or male sex.
Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
Age ≥18 years at A/MBC diagnosis.
Initiated palbociclib in combination with an AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019. Note that the date of the start of the inclusion period reflects the month of palbociclib US FDA approval.
Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

Who cannot join

Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
Evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.

Trial locations and contacts

1 site in 1 country.

United States1 site

Syapse
San Francisco, California, 94107

Other trials in United States

About this study

Official title: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving Palbociclib + Aromatase Inhibitor (AI) Combination Therapy as First-Line Treatment

Conditions: Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04394247
Study group	Role	What they receive
Breast Cancer Patients		HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Treatment Regimen Distribution
Regimen medications were defined as systemic therapies included in line regimen based on synapse line of therapy algorithm. Treatment regimen distribution included: first-line regimen; palbociclib along with aromatase inhibitor and second-line regimen; CDK4/6 inhibitor plus endocrine and chemotherapy. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Measured: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of Participants With Sequence of Treatment Lines
Line of therapy was defined as line number (1; 2; 3; etc.) in the A/MBC setting assigned based on synapse line of therapy algorithm. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Measured: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of Participants With Their Starting Dose and End Dose
Percentage of participants with starting and end dose at 125 mg, 100 mg, 75 mg and unknown were reported.
Measured: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of Participants With Type of Dose Adjustment
In this outcome measure type of dose adjustments were recorded and reported. It included dose increase, decrease, no adjustment and unknown categories.
Measured: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of Participants With Their Reason For Treatment Discontinuation
Percentage of participants with discontinuation reason as progression, intolerance/toxicity, participant choice, treatment for other diseases, left health system, end of planned therapy, changes in insurance, death, hospice referral, physician choice, actionable mutation found, other/unknown were recorded and reported in this outcome measure.
Measured: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Time to Dose Adjustment
Time to dose adjustment (TTDA) was defined as the time from the start of palbociclib and AI treatment until the date of treatment dose adjustment.
Measured: From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years
Probability of Real-World Progression-Free Survival (rwPFS) at Month 3
Probability of being event free (event defined as disease progression [PD] or death due to any cause) at 3 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 6
Probability of being event free (event defined as PD or death due to any cause) at 6 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 12
Probability of being event free (event defined as PD or death due to any cause) at 12 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 18
Probability of being event free (event defined as PD or death due to any cause) at 18 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 24
Probability of being event free (event defined as PD or death due to any cause) at 24 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 30
Probability of being event free (event defined as PD or death due to any cause) at 30 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Real-World Progression-Free Survival (rwPFS) at Month 36
Probability of being event free (event defined as PD or death due to any cause) at 36 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 3
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 6
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 12
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 18
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 24
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 30
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Real-World Overall Survival (rwOS) at Month 36
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3
Probability of participants without first-line treatment discontinuation or death at month 3 were reported in this outcome measure. Real-world time to treatment discontinuation (rwTTD) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6
Probability of participants without first-line treatment discontinuation or death at month 6 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12
Probability of participants without first-line treatment discontinuation or death at month 12 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18
Probability of participants without first-line treatment discontinuation or death at month 18 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24
Probability of participants without first-line treatment discontinuation or death at month 24 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30
Probability of participants without first-line treatment discontinuation or death at month 30 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36
Probability of participants without first-line treatment discontinuation or death at month 36 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3
Probability of participants without subsequent line of therapy initiation or death at month 3 were reported in this outcome measure. Real-world time to next treatment (rwTTNT) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6
Probability of participants without subsequent line of therapy initiation or death at month 6 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12
Probability of participants without subsequent line of therapy initiation or death at month 12 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18
Probability of participants without subsequent line of therapy initiation or death at month 18 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24
Probability of participants without subsequent line of therapy initiation or death at month 24 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30
Probability of participants without subsequent line of therapy initiation or death at month 30 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36
Probability of participants without subsequent line of therapy initiation or death at month 36 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 3
Probability of participants without subsequent chemotherapy or death at month 3 were reported in this outcome measure. Real-world time to chemotherapy (rwTTC) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 6
Probability of participants without subsequent chemotherapy or death at month 6 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 12
Probability of participants without subsequent chemotherapy or death at month 12 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 18
Probability of participants without subsequent chemotherapy or death at month 18 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 24
Probability of participants without subsequent chemotherapy or death at month 24 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 30
Probability of participants without subsequent chemotherapy or death at month 30 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Participants Without Subsequent Chemotherapy or Death at Month 36
Probability of participants without subsequent chemotherapy or death at month 36 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3
Probability of participants without a first-line therapy dose adjustment at month 3 were reported in this outcome measure. Real-world time to dose adjustment (rwTTDA) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 3 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6
Probability of participants without a first-line therapy dose adjustment at month 6 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 6 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12
Probability of participants without a first-line therapy dose adjustment at month 12 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 12 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18
Probability of participants without a first-line therapy dose adjustment at month 18 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 18 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24
Probability of participants without a first-line therapy dose adjustment at month 24 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 24 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30
Probability of participants without a first-line therapy dose adjustment at month 30 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 30 months after treatment initiation any time during 5 years of study period
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36
Probability of participants without a first-line therapy dose adjustment at month 36 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Measured: 36 months after treatment initiation any time during 5 years of study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202031 Dec 2020

First posted19 May 2020
Study start30 Jun 2020
Primary completion31 Dec 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04394247
Sponsor's protocol ID: A5481155
Status last verified: Mar 2023
First submitted: 15 May 2020
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Law JW, Mitra D, Kaplan HG, Alfred T, Brufsky AM, Emir B, McCracken H, Liu X, Broome RG, Zhang C, DiCristo C, Chen C. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Curr Oncol. 2022 Feb 12;29(2):1047-1061. doi: 10.3390/curroncol29020089.
PubMed 35200588

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See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving Palbociclib + Aromatase Inhibitor (AI) Combination Therapy as First-Line Treatment
ClinicalTrials.gov ID: NCT04394247
Acronym / sponsor ID: A5481155
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Jun 2020 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 19 May 2020 (actual)
Results: Posted 21 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Breast Cancer Patients	–	–HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated palbociclib combination therapy with AI as the first-line therapy on or after 03 February 2015 up to and including 31 July 2019.

Key inclusion criteria (6 listed)

Female or male sex.
Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
Age ≥18 years at A/MBC diagnosis.
Initiated palbociclib in combination with an AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019. Note that the date of the start of the inclusion period reflects the month of palbociclib US FDA approval.
Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).

Key exclusion criteria (3 listed)

Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
Evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With Treatment Regimen Distribution
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Regimen medications were defined as systemic therapies included in line regimen based on synapse line of therapy algorithm. Treatment regimen distribution included: first-line regimen; palbociclib along with aromatase inhibitor and second-line regimen; CDK4/6 inhibitor plus endocrine and chemotherapy. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Percentage of Participants With Sequence of Treatment Lines
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Line of therapy was defined as line number (1; 2; 3; etc.) in the A/MBC setting assigned based on synapse line of therapy algorithm. Systemic anticancer treatment here refers to one or more sequential monotherapy or combination therapy regimens occurring within discrete lines of treatment, each ending with a disease progression.
Percentage of Participants With Their Starting Dose and End Dose
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of participants with starting and end dose at 125 mg, 100 mg, 75 mg and unknown were reported.
Percentage of Participants With Type of Dose Adjustment
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
In this outcome measure type of dose adjustments were recorded and reported. It included dose increase, decrease, no adjustment and unknown categories.
Percentage of Participants With Their Reason For Treatment Discontinuation
Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years
Percentage of participants with discontinuation reason as progression, intolerance/toxicity, participant choice, treatment for other diseases, left health system, end of planned therapy, changes in insurance, death, hospice referral, physician choice, actionable mutation found, other/unknown were recorded and reported in this outcome measure.
Time to Dose Adjustment
Time frame: From start of treatment till treatment dose adjustment, up to a maximum of approximately 5 years
Time to dose adjustment (TTDA) was defined as the time from the start of palbociclib and AI treatment until the date of treatment dose adjustment.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as disease progression [PD] or death due to any cause) at 3 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 6 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 12 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 18 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 24 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 30 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Progression-Free Survival (rwPFS) at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
Probability of being event free (event defined as PD or death due to any cause) at 36 months. rwPFS was defined as the extent of time from the start of palbociclib and AI treatment until disease progression, date of death prior to initiation of the 2nd line treatment. Participants who were not indicated to be deceased at the time of analysis were censored for rwPFS analysis at the date of initiation of the 2nd line treatment, date of last contact or the end of study period whichever occurred first. Probability of participants with rwPFS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 3 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 6 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 12 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 18 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 24 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 30 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Real-World Overall Survival (rwOS) at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
rwOS was defined as the time from the start of palbociclib and AI treatment until the date of death, date of last contact or the end of study period. Participants who were not indicated to be deceased at the time of analysis were censored for rwOS analysis at the date of last contact or the end of study period whichever occurred first. Probability of participants with rwOS at 36 months were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 3 were reported in this outcome measure. Real-world time to treatment discontinuation (rwTTD) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 6 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 12 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 18 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 24 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 30 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without First Line Treatment Discontinuation or Death at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
Probability of participants without first-line treatment discontinuation or death at month 36 were reported in this outcome measure. rwTTD was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date the participant discontinued first-line therapy or date of death. Participant alive and without first-line therapy discontinuation were censored at the earliest of last known use of first-line therapy or end of study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 3 were reported in this outcome measure. Real-world time to next treatment (rwTTNT) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 6 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 12 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 18 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 24 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 30 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Line of Therapy Initiation or Death at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent line of therapy initiation or death at month 36 were reported in this outcome measure. rwTTNT was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent line of treatment, date of death, date of last contact or the end of study period. Participant alive and without subsequent line of therapy initiation were censored at the earliest of the following events: date of last contact or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 3 were reported in this outcome measure. Real-world time to chemotherapy (rwTTC) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 6 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 12 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 18 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 24 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 30 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without Subsequent Chemotherapy or Death at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
Probability of participants without subsequent chemotherapy or death at month 36 were reported in this outcome measure. rwTTC was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: start of subsequent chemotherapy or date of death. Participant alive and without subsequent chemotherapy were censored at the earliest of the following events: date of last contact or end of the study period, whichever came later. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 3
Time frame: 3 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 3 were reported in this outcome measure. Real-world time to dose adjustment (rwTTDA) was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 6
Time frame: 6 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 6 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 12
Time frame: 12 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 12 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 18
Time frame: 18 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 18 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 24
Time frame: 24 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 24 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 30
Time frame: 30 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 30 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.
Probability of Participants Without a First Line Therapy Dose Adjustment at Month 36
Time frame: 36 months after treatment initiation any time during 5 years of study period
Probability of participants without a first-line therapy dose adjustment at month 36 were reported in this outcome measure. rwTTDA was defined as length of time from the start of first-line therapy with palbociclib plus an aromatase inhibitor to the earliest of one the following: date of first-line treatment dose adjustment or discontinuation, date of death, date of last contact or the end of study period. Participant alive and without a first-line therapy dose adjustment were censored at the earliest of the following events: first-line discontinuation, death, date of last contact, or end of the study period. Analysis was performed using Kaplan-Meier method.

Results and safety

Results posted to the registry on 21 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palbociclib With Aromatase Inhibitor	242	242

Primary outcome: Percentage of Participants With Treatment Regimen Distribution

Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years. Number. Unit: Percentage of participants

Measure	Palbociclib With Aromatase Inhibitor n = 242
First-line regimen	100
Second-line regimen	39.67

Population analysed: Analysis population included all participants who met following criteria: 1) Diagnosis of A/MBC; 2) Aged \>=18 years at A/MBC diagnosis; 3) Initiated palbociclib in combination with AI as first-line therapy after A/MBC diagnosis on or after 03 February 2015 through 31 July 2019; 4) Evidence of ER or PR positive disease and HER2 negative disease or absence of any indication of ER and PR negative disease and HER2 positive disease closest to A/MBC diagnosis.

Primary outcome: Percentage of Participants With Sequence of Treatment Lines

Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years. Number. Unit: Percentage of participants

Measure	Palbociclib With Aromatase Inhibitor n = 242
1 Line	100
2 Lines	21.49
3 Lines	12.81
4 Lines	2.07
5 Lines or more	3.31

Primary outcome: Percentage of Participants With Their Starting Dose and End Dose

Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years. Number. Unit: Percentage of participants

Measure	Palbociclib With Aromatase Inhibitor n = 242
Starting Dose: 125 mg	89.7
Starting Dose: 100 mg	7.4
Starting Dose: 75 mg	1.2
Starting Dose: Unknown	1.7
End Dose: 125 mg	60.7
End Dose: 100 mg	27.7
End Dose: 75 mg	9.9
End Dose: Unknown	1.7

Primary outcome: Percentage of Participants With Type of Dose Adjustment

Time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years. Number. Unit: Percentage of participants

Measure	Palbociclib With Aromatase Inhibitor n = 242
Increase	0.4
Decrease	31.0
No adjustment	66.9
Unknown	1.7

Adverse events

Time frame: All-Cause Mortality: From start of treatment up to a maximum of approximately 5 years. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib With Aromatase Inhibitor	0 of 0	0 of 0	62 of 242

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35200588Law JW, Mitra D, Kaplan HG, Alfred T, Brufsky AM, Emir B, McCracken H, Liu X, Broome RG, Zhang C, DiCristo C, Chen C. Real-World Treatment Patterns and Clinical Effectiveness of Palbociclib Plus an Aromatase Inhibitor as First-Line Therapy in Advanced/Metastatic Breast Cancer: Analysis from the US Syapse Learning Health Network. Curr Oncol. 2022 Feb 12;29(2):1047-1061. doi: 10.3390/curroncol29020089.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment Regimen Distribution (time frame: From start of treatment to end of follow-up, up to a maximum of approximately 5 years). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.