PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
Trial Parameters
Brief 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)
Eligibility Criteria
* Eligibility criteria prior to 1L treatment: 1. Histologically confirmed metastatic breast cancer with or without measurable disease 2. Patients who have stage IV breast cancer at diagnosis (de novo) or have progressed on distant metastatic sites after curative surgery: locally advanced disease not amenable to distant metastasis are eligible as well as disease with distant metastasis 3. Confirmed germline pathogenic BRCA1 and/or 2 mutation or 35 HRD-related gene alterations (see Appendix 16.5) 4. age \> 19 years 5. ECOG performance status 0 - 2 6. Patient has HER2 IHC0, IHC1+, or ICH2+/ISH-, as determined according to ASCO/CAP guidelines breast cancer 7. Patient has ER positive and/or PgR positive according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as 1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally 8. Female patients should be premenopausal. Premenopausal status is defined as e