Premenopausal HR+/HER2- Metastatic Breast Cancer Clinical Trial
Official title:
Randomized Phase II Study of Talazoparib Versus Talazoparib Plus Atezolizumab After Palbociclib Combination Endocrine Therapy for Patients With Premenopausal HR+/HER2- Metastatic Breast Cancer Harboring HRD Scar
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)
1. st line treatment - Palbociclib: A capsule will be administered once a day for 21 days and rest for 7 days (1cycle=28days) - AI treatment: D1~28 days. Take once a day. Prescribed according to local prescribe guideline. - GnRH agonist: At D1 for every cycle with 4 week (+3days) interval via subcutaneous injection. 2. nd line treatment 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) - Talazoparib: Take orally once a day at the same time - Atezolizumab: 1,200mg, at D1 of each cycle. Applicable for arm A only. ;