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

Sponsor
Samsung Medical Center
Study ID
NCT04819243
Phase
PHASE2
Status
Recruiting
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Conditions

  • Premenopausal HR+/HER2- Metastatic Breast Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Aug 25, 2021
Status verified
Jan 2025
Primary completion
Dec 30, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab+Talazoparib
    1. st line treatment * Palbociclib 125mg po D1-21 * AI : Prescribed as per local guideline * GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist) 2. nd line treatment * Talazoparib 1mg po * Atezolizumab 1200mg IV (3week)
  • Experimental: Talazoparib
    1. st line treatment * Palbociclib 125mg po D1-21 * AI : Prescribed as per local guideline * GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist) 2. nd line treatment - Talazoparib 1mg po

Primary Outcome Measure

2nd Progression free survival (PFS) [ Time Frame: The time until the time of the first event(the progression of a recorded disease of breast cancer or death from all causes) in 2nd line treatment. Up to 72months ]

Central Contacts