N/A
N=84
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04987931 ↗Enrolled (actual)
84
Serious AEs
—
Results posted
Jan 2024
Primary outcome: Primary: Time to Treatment Failure (TTF) for Talazoparib — 8.5 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Talazoparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Treatment Failure (TTF) for Talazoparib |
8.5 | — |
| SECONDARY Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib |
8.7 | — |
| SECONDARY Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy |
12.2 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT04987931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.