NCT04756765

Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer

A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to test if talazoparib is safe and evaluate its response to advanced breast cancer associated with mutation of gene called PALB.

Detailed 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) 1. To evaluate the safety of talazoparib in subjects with advanced PALB2 mutation associated breast cancer 2. To evaluate the progression free survival (PFS) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer 3. To evaluate the clinical benefit rate (CBR) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer 4. 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 5. To evaluate patient reported quality of life on talazoparib monotherapy

Conditions

• Breast Cancer
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Talazoparib Tosylate	Talazoparib1 mg/day is to be administered orally on a continuous dosing schedule.

Timeline

• Start date: 2023-02-23
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2021-02-16
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study