RecruitingPhase 2NCT04819243

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


Sponsor

Samsung Medical Center

Enrollment

178 participants

Start Date

Aug 25, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the best treatment sequence for people with metastatic (spread) breast cancer who have certain inherited gene mutations linked to DNA repair (including BRCA1/2 and related genes). Researchers are comparing different combinations of targeted therapies, including a CDK4/6 inhibitor, hormonal therapy, a PARP inhibitor, and an immunotherapy drug. **You may be eligible if...** - You have been diagnosed with metastatic (stage IV) breast cancer - You have a confirmed mutation in BRCA1, BRCA2, or one of 35 related DNA repair genes - Your breast cancer is HER2-negative - You are 19 years of age or older - You are in reasonably good health (able to care for yourself) - You have not received prior treatment for your metastatic disease **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You are under 19 years old - You have received prior treatment for metastatic breast cancer - You have poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab

* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib * Atezolizumab

DRUGPabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,

* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib


Locations(1)

Samsung medical Center

Seoul, Gannam-gu, South Korea

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NCT04819243