Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
- Sponsor
- UNICANCER
- Study ID
- NCT04053322
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer
- a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUGDurvalumab will start 4 weeks after the first dose of olaparib (Cycle 2, Day 1) at 1500 mg intravenous (IV) every 4 weeks.
- Olaparib — DRUG2 x 150 mg tablets taken in the morning and in the evening orally (2 X 300 mg daily)
- Fulvestrant — DRUGTwo intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15, and then Day 1 of each subsequent 28-day cycle.
Study Details
This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations or alterations of genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI) status.
Key Dates
- Start date
- Aug 26, 2019
- Status verified
- Feb 2025
- Primary completion
- Nov 15, 2023
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 172 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Study Arm
Primary Outcome Measure
Progression-free survival rate (PFSR) [ Time Frame: 24 weeks ]