Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m HER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib. |
Drug: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Time-to-treatment failure for talazoparib for primary population [Up to 36 months]
Time from initiation of talazoparib to discontinuation for any reason, including disease progression, treatment toxicity, and death for primary population
Secondary Outcome Measures
- Real-world progression free survival for talazoparib for primary population [Up to 36 months]
Time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurs first for primary population
- Time from initiation of talazoparib to chemotherapy for primary population [Up to 36 months]
Time from initiation of talazoparib to initiation of subsequent chemotherapy for primary population
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Inc | New York | New York | United States | 10017 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C3441053