Trials / Active Not Recruiting
Active Not RecruitingNCT04053322
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
An International Multicenter Phase II Trial of Durvalumab (MEDI4736) Plus OLAparib Plus Fulvestrant in Metastatic or Locally Advanced ER-positive, HER2-negative Breast Cancer Patients Selected Using Criteria That Predict Sensitivity to Olaparib
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Durvalumab will start 4 weeks after the first dose of olaparib (Cycle 2, Day 1) at 1500 mg intravenous (IV) every 4 weeks. |
| DRUG | Olaparib | 2 x 150 mg tablets taken in the morning and in the evening orally (2 X 300 mg daily) |
| DRUG | Fulvestrant | Two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15, and then Day 1 of each subsequent 28-day cycle. |
Timeline
- Start date
- 2019-08-26
- Primary completion
- 2023-11-15
- Completion
- 2027-08-01
- First posted
- 2019-08-12
- Last updated
- 2025-03-12
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04053322. Inclusion in this directory is not an endorsement.