Breast Cancer MetastaticNCT05155566
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
An observational study of Breast Cancer Metastatic, run by Pfizer at 2 sites in 2 countries.
Trial summary
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastatic
- How many people
- 847 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 May 2019to 12 Mar 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective medical data review of patients who have received palbociclib combination treatments as first line treatment regardless of combination partner and labelled use in Argentina, Chile, Peru, Mexico and a combined sample in Costa Rica and Panama.
Physician inclusion criteria:
- Oncologist or gynecologist.
- Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
- Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.
Patient inclusion criteria:
- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
- Received palbociclib as a first line therapy.
- No prior or current enrolment in an interventional clinical trial for ABC/MBC.
- Minimum of six months of follow up data since palbociclib initiation.
Physician exclusion criteria:
- Qualified less than 2 years ago or more than 35 years ago.
- Participated in observational research for ABC/MBC in the last 3 months.
- Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK
Bollington, Chesshire, SK105JB
About this study
Official title: Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
- Conditions
- Breast Cancer Metastatic
- Keywords
- human epidermal growth factor receptor 2 negative (HER2-), hormone receptor positive (HR+), advanced breast cancer (ABC), metastatic breast cancer (MBC)
- 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 Latin America |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Rate at Month 6
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Measured: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Progression Free Rate at Month 12
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Measured: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Progression Free Rate at Month 18
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Measured: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Progression Free Rate at Month 24
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Measured: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Objective Response Rate
Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Measured: From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation
Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.
Measured: 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation
Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Measured: 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) >=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.
Measured: From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib
SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Measured: From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Survival Rate at Month 6
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Measured: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Survival Rate at Month 12
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Measured: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Survival Rate at Month 18
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Measured: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Survival Rate at Month 24
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Measured: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Time From Palbociclib Initiation to Initial Response Recorded
CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Measured: From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Time From Palbociclib Initiation to Complete Response
CR was defined as complete resolution of all visible disease per the treating physicians opinion.
Measured: From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Time From Palbociclib Initiation to Partial Response
PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Measured: From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Follow-up Time Since Palbociclib Initiation
Measured: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of Participants With Supportive Therapies
Number of participants who received supportive therapies during palbociclib treatment were reported.
Measured: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Ongoing Palbociclib Treatment
Measured: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Discontinued Palbociclib Treatment
Measured: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of Participants According to Therapies Received Post Palbociclib Treatment
Number of participants who received therapies post palbociclib treatment were reported.
Measured: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Time From Palbociclib Initiation to First Dose Reduction
Measured: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Dose Interruption
Measured: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Cycle Delays
Measured: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 May 2019
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
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 Cancer MetastaticStudies 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
- 847 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
- NCT05155566
- Sponsor's protocol ID
- A5481125
- Other IDs
- IRIS LATAM
- Status last verified
- May 2023
- First submitted
- 9 Dec 2021
- Last updated
- 26 Jan 2024
- 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings
- ClinicalTrials.gov ID
- NCT05155566
- Acronym / sponsor ID
- A5481125
- Conditions
- Breast Cancer Metastatic
- Keywords
- human epidermal growth factor receptor 2 negative (HER2-), hormone receptor positive (HR+), advanced breast cancer (ABC), metastatic breast cancer (MBC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 847 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Posted 26 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.
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 Latin America |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective medical data review of patients who have received palbociclib combination treatments as first line treatment regardless of combination partner and labelled use in Argentina, Chile, Peru, Mexico and a combined sample in Costa Rica and Panama.
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
Progression Free Rate at Month 6
Time frame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Progression Free Rate at Month 12
Time frame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Progression Free Rate at Month 18
Time frame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Progression Free Rate at Month 24
Time frame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Objective Response Rate
Time frame: From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation
Time frame: 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.
Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation
Time frame: 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)
Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Clinical Benefit Rate
Time frame: From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) >=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.
Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib
Time frame: From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Survival Rate at Month 6
Time frame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Survival Rate at Month 12
Time frame: Month 12 (from the data collected and observed retrospectively for approximately 22 months)
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Survival Rate at Month 18
Time frame: Month 18 (from the data collected and observed retrospectively for approximately 22 months)
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Survival Rate at Month 24
Time frame: Month 24 (from the data collected and observed retrospectively for approximately 22 months)
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Time From Palbociclib Initiation to Initial Response Recorded
Time frame: From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Time From Palbociclib Initiation to Complete Response
Time frame: From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
CR was defined as complete resolution of all visible disease per the treating physicians opinion.
Time From Palbociclib Initiation to Partial Response
Time frame: From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Follow-up Time Since Palbociclib Initiation
Time frame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of Participants With Supportive Therapies
Time frame: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of participants who received supportive therapies during palbociclib treatment were reported.
Duration of Ongoing Palbociclib Treatment
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Discontinued Palbociclib Treatment
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of Participants According to Therapies Received Post Palbociclib Treatment
Time frame: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Number of participants who received therapies post palbociclib treatment were reported.
Time From Palbociclib Initiation to First Dose Reduction
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Dose Interruption
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Duration of Cycle Delays
Time frame: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- 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.
Related trials for Breast Cancer Metastatic
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic, run by Pfizer at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, United Kingdom. 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 26 Jan 2024). 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?
Progression Free Rate at Month 6 (time frame: Month 6 (from the data collected and observed retrospectively for approximately 22 months)). The study lists 24 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 26 Jan 2024.