Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Talazoparib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m<br>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<br>* 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.<br>* Other names: TALZENNA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-treatment failure for talazoparib for primary population | Time from initiation of talazoparib to discontinuation for any reason, including disease progression, treatment toxicity, and death for primary population | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world progression free survival for talazoparib for primary population | Time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurs first for primary population | Up to 36 months | 
| Time from initiation of talazoparib to chemotherapy for primary population | Time from initiation of talazoparib to initiation of subsequent chemotherapy for primary population | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Talazoparib, Breast Cancer