NCT04819243

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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. (or ET + CDK4/6 inhibitors + GnRH agonist) 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.

Conditions

• Premenopausal HR+/HER2- Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab	* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib * Atezolizumab
DRUG	Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,	* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib

Timeline

• Start date: 2021-08-25
• Primary completion: 2025-12-30
• Completion: 2027-12-31
• First posted: 2021-03-26
• Last updated: 2025-01-03

Locations

1 site across 1 country: South Korea