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

    • New York
      • New York, New York, United States, 10017
        • Pfizer United States

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:

    1. Diagnosed with locoregional recurrent or metastatic female breast cancer.
    2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
    3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

      1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
      2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
    4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
    5. ≥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
Breast Cancer Patients
HR+/HER2- metastatic breast cancer patients in the US.

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

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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