Breast CancerNCT04396626
HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
An observational study of Breast Cancer, run by Pfizer at 1 site in United States.
Trial summary
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC 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
- 975 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 31 May 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 CDK4/6i combination therapy with AI as the initial endocrine-based therapy on or after 2/3/2015 and before 4/1/2019.
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 a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.
- •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. 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
- 1. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving CDK4/6i + Aromatase Inhibitor (AI) Combination Therapy as Initial Endocrine-based Treatment
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.
- 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 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.
Number of Participants With Different Type of Treatment Regimens
Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants Who Received Different Treatment Sequence Across Lines
Lines of therapy was defined as the following progression-based lines, in which a disease progression must occur for a new regimen to be interpreted as a new line of therapy. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants With Start and End Dose of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Duration of Treatment of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants With Reason for Treatment Discontinuation of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Time to Dose Discontinuation of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants With Type of Dose Adjustments of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Time to First Dose Adjustment of CDK4/6 Inhibitors
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Real Progression Free Survival (rwPFS)
rwPFS was defined as the time from the index date to disease progression, death, or end of record or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Overall Survival (OS)
OS was defined as the time between the index date to disease progression, death due to any cause or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Real-World Tumor Response (rwTR)
rwTR was defined as the best overall response for each regimen. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), not evaluable (NE), or undocumented. The date of the first positive response (CR or PR) and of the best overall response for each regimen was collected. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD: no change in size of visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Time to First Positive Response
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Duration of Response (DOR)
DOR: time from first documented occurrence of response (CR or PR) until date of first documented PD or death due to underlying cancer. Participants without a PD assessment or death were censored at the data cutoff date. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Duration of Initial Endocrine-based Treatment
Measured: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)
Duration of Treatment
Measured: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)
Duration of Follow-up
Measured: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start18 Nov 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: The study was prematurely discontinued due to significant data quality issues on August 26, 2021. There were no safety concerns that led to the decision to terminate.
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.
- 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
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396626
- Sponsor's protocol ID
- A5481144
- Other IDs
- Concerto
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2020
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 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 CDK4/6i + Aromatase Inhibitor (AI) Combination Therapy as Initial Endocrine-based Treatment
- ClinicalTrials.gov ID
- NCT04396626
- Acronym / sponsor ID
- A5481144
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to significant data quality issues on August 26, 2021. There were no safety concerns that led to the decision to terminate.
- Enrolment
- 975 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 21 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.
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 CDK4/6i combination therapy with AI as the initial endocrine-based therapy on or after 2/3/2015 and before 4/1/2019.
Key inclusion criteria (7 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 a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.
- •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval.
Key exclusion criteria (1 listed)
- 1. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
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
Number of Participants With Different Type of Treatment Regimens
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
Number of Participants Who Received Different Treatment Sequence Across Lines
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Lines of therapy was defined as the following progression-based lines, in which a disease progression must occur for a new regimen to be interpreted as a new line of therapy. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Number of Participants With Start and End Dose of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Duration of Treatment of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants With Reason for Treatment Discontinuation of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Time to Dose Discontinuation of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Number of Participants With Type of Dose Adjustments of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Time to First Dose Adjustment of CDK4/6 Inhibitors
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Real Progression Free Survival (rwPFS)
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
rwPFS was defined as the time from the index date to disease progression, death, or end of record or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Overall Survival (OS)
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
OS was defined as the time between the index date to disease progression, death due to any cause or end of data availability, whichever comes first. Index date was defined as the date of A/MBC diagnosis. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination
Real-World Tumor Response (rwTR)
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
rwTR was defined as the best overall response for each regimen. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), not evaluable (NE), or undocumented. The date of the first positive response (CR or PR) and of the best overall response for each regimen was collected. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD: no change in size of visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Time to First Positive Response
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Duration of Response (DOR)
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
DOR: time from first documented occurrence of response (CR or PR) until date of first documented PD or death due to underlying cancer. Participants without a PD assessment or death were censored at the data cutoff date. CR: Complete resolution of all visible disease. PR: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Duration of Initial Endocrine-based Treatment
Time frame: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)
Duration of Treatment
Time frame: From the start date of the initial endocrine-based therapy to the end date of the initial endocrine-based therapy (during 15 months of retrospective observation period)
Duration of Follow-up
Time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 7 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Apr 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 2022). 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?
Number of Participants With Different Type of Treatment Regimens (time frame: From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.