Clinical trial

Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review

Name
C3441053
Description
This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN). This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US. The primary population for this study includes: -HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
Trial arms
Trial start
2021-08-20
Estimated PCD
2021-10-11
Trial end
2021-10-11
Status
Completed
Treatment
Talazoparib
This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
Arms:
Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m
Other names:
TALZENNA®
Size
84
Primary endpoint
Time to Treatment Failure (TTF) for Talazoparib
Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
Eligibility criteria
Inclusion Criteria: * Diagnosed with HER2-negative ABC * gBRCA1/2 mutation(s) * Treatment with talazoparib monotherapy initiated on or after October 16, 2018 -≥18 years of age at initiation of talazoparib * A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period Exclusion Criteria: * Participation in any BC clinical trial after initiation of talazoparib * Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy * gBRCA1/2 or HER2 status unknown * Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}
Updated at
2024-01-22

1 organization

1 product

1 indication

Indication
Breast Cancer
Organization
Pfizer