TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04498481
• Lead Sponsor: Pfizer

Brief Summary

This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.

• Female.
• Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
• Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
• Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
• Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
• Age greater than or equal to 18 years at A/MBC diagnosis.

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Exclusion Criteria

-There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving various cancer treatment regimens	A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving each therapy sequence across lines	A/MBC diagnosis through end of study (assessed up to 24 months)
Treatment persistence	A/MBC diagnosis through end of study (assessed up to 24 months)
Progression Free Survival (PFS)	A/MBC diagnosis through end of study (assessed up to 24 months)
Tumor response rate	A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients that experience dose adjustment	A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients who discontinue therapy	A/MBC diagnosis through end of study (assessed up to 24 months)

Trial Locations

Locations (1)

Pfizer United States; 🇺🇸 New York, New York, United States