Status:
COMPLETED
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.
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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 combinat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04498481
Start Date
March 1 2018
End Date
July 1 2018
Last Update
August 4 2020
Active Locations (1)
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1
Pfizer United States
New York, New York, United States, 10017