PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
- Conditions
- Premenopausal HR+/HER2- Metastatic Breast Cancer
- Interventions
- Drug: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,
- Registration Number
- NCT04819243
- Lead Sponsor
- Samsung Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Talazoparib Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), 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+Talazoparib Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab 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)
- Primary Outcome Measures
Name Time Method 2nd Progression free survival (PFS) 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 To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Toxicity assessment from the date of informed consent signature to 28 days after last drug administration Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v5.0
Composite PFS (1st PFS + 2nd PFS) The time from the day 1 of first therapy to the time of first event (documented disease progression of breast cancer or death due to any cause) in 1st and 2nd line therapy. Up to 72months To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
Overall survival (OS) Survival will be measured as the time from the randomization occurs after Progression of 1st line to the date of death. Up to 72months To assess secondary measures of clinical efficacy.
Quality of Life (QoL) from the date of informed consent signature to 28 days after last drug administration The QoL will be evaluated using EQ5D
Trial Locations
- Locations (1)
Samsung medical Center
🇰🇷Seoul, Gannam-gu, Korea, Republic of