Status:
TERMINATED
HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with ar...
Eligibility Criteria
Inclusion
- Female or male sex.
- Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
- Age ≥18 years at A/MBC diagnosis.
- Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.
- •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval.
- Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
- Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).
Exclusion
- 1\. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Key Trial Info
Start Date :
November 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT04396626
Start Date
November 18 2019
End Date
May 31 2020
Last Update
April 27 2023
Active Locations (1)
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1
Pfizer United States
New York, New York, United States, 10017