drugset / Trial / NCT04819243

PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study

NCT04819243

Phase 2 Recruiting 178 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar 1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line treatment(., randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)

Timeline

Start
2021-08-25
Primary completion
2025-12-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Talazoparib Small molecule 1 mg Oral
Background Palbociclib Small molecule 125 mg Oral