Actively Recruiting
PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
Led by Samsung Medical Center · Updated on 2025-01-03
178
Participants Needed
1
Research Sites
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic breast cancer with or without measurable disease
- Stage IV breast cancer at diagnosis or progression on distant metastatic sites after curative surgery
- Confirmed germline pathogenic BRCA1 and/or BRCA2 mutation or 35 HRD-related gene alterations
- Age over 19 years
- ECOG performance status 0 to 2
- HER2 status IHC0, IHC1+, or IHC2+/ISH- according to ASCO/CAP guidelines
- ER positive and/or PgR positive defined as 1% or more tumor cells stained positive
- Female patients must be premenopausal with defined criteria for menopausal status
- Eligible treatment history including specific prior therapies and chemotherapy restrictions
- No possibility of pregnancy or negative pregnancy test
- Adequate bone marrow, renal, and liver function as specified
- Patients may continue bisphosphonate or denosumab therapy
- Agreement to use effective contraception or no childbearing potential
- Written informed consent
- Agreement to provide tumor tissue and blood for biomarker analysis
You will not qualify if you...
- Postmenopausal women except those with bilateral salpingo oophorectomy
- Serious uncontrolled infections within 4 weeks prior to treatment
- Serious medical or psychiatric illness including active cardiac disease
- Pregnant or breastfeeding women or those intending pregnancy during or within 5 months after treatment
- Second primary malignancy except certain treated cancers with no recurrence
- Previous endocrine treatments in metastatic setting except tamoxifen ± GnRH agonist
- Previous aromatase inhibitor treatment within 1 year
- Previous CDK4/6 inhibitors, PARP1 inhibitors, or immune checkpoint inhibitors within 1 year
- Known brain metastases
- History of significant liver disease, alcohol abuse, or active infection
- History of autoimmune diseases including multiple specified conditions
- Prior allogeneic stem cell or solid organ transplantation
- History or evidence of pneumonitis or active pulmonary fibrosis
- Active tuberculosis
- Receipt of live, attenuated vaccine within 4 weeks prior to treatment or planned during study
- Treatment with systemic immunostimulatory agents within 4 weeks prior to treatment
- Treatment with systemic corticosteroids or immunosuppressive medications within 2 weeks prior to treatment or planned during trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung medical Center
Seoul, Gannam-gu, South Korea, 06351
Actively Recruiting
Research Team
Y
Yeon Hee Park, phD
CONTACT
M
mieun Kim, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here