- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04460898
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
April 9, 2022 updated by: Pfizer
Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
195
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10017
- Pfizer United States
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- mBC and received treatment with Palbociclib in combination with letrozole as initial endocrine-therapy for advanced/metastatic breast cancer.
Description
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Diagnosed with locoregional recurrent or metastatic female breast cancer.
- Pathologically confirmed HR-positive/HER2-negative diagnosis.
Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:
- Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
- At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
- Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
≥18 year old at initiation of palbociclib.
Exclusion Criteria:
- No exclusion criteria will be imposed for the selection of patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast Cancer Patients
HR+/HER2- metastatic breast cancer patients in the US.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival (PFS)
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Tumor response
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Proportion of patients receiving various cancer treatment regimens
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Proportion of patients receiving each therapy sequence across lines
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Proportion of patients receiving each starting dose and end dose for those on palbociclib combination therapy
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Proportion of patients that experienced dose adjustment
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Proportion of patients that discontinued therapy
Time Frame: mBC diagnosis through end of study (assessed up to 24 months)
|
mBC diagnosis through end of study (assessed up to 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2019
Primary Completion (Actual)
June 24, 2019
Study Completion (Actual)
June 24, 2019
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 9, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5481123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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