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

NCT04819243 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-01-03

No results posted yet for this study

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)

Conditions

  • Premenopausal HR+/HER2- Metastatic Breast Cancer

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819243 on ClinicalTrials.gov