Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Breast Cancer
- Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objectives: To evaluate whether talazoparib monotherapy can induce a 30% rate of objective response in subjects with advanced breast cancer associated with a PALB2 mutation. Secondary Objective(s) To evaluate the safety of talazoparib in subjects with advanced PALB2 mutation associated breas...
Primary Objectives: To evaluate whether talazoparib monotherapy can induce a 30% rate of objective response in subjects with advanced breast cancer associated with a PALB2 mutation. Secondary Objective(s) To evaluate the safety of talazoparib in subjects with advanced PALB2 mutation associated breast cancer To evaluate the progression free survival (PFS) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer To evaluate the clinical benefit rate (CBR) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer To evaluate the ability of circulating tumor DNA (ctDNA) to identify and characterize the nature of PALB2 mutations at baseline and upon progression in subjects with advanced PALB2 mutation associated breast cancer treated with talazoparib monotherapy To evaluate patient reported quality of life on talazoparib monotherapy
Tracking Information
- NCT #
- NCT04756765
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Melinda Telli Stanford Universiy
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