NCT04053322View on ClinicalTrials.gov

Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

August 26, 2019

Primary Completion Date

November 15, 2023

Study Completion Date

August 31, 2027

Conditions
ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancera Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status
Interventions
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.

Trial Locations (2)

34000

Institut de Cancerologie de Montpellier, Montpellier

76000

Centre Henri-Becquerel, Rouen

All Listed Sponsors
collaborator

ARCAGY/ GINECO GROUP

OTHER

collaborator

SOLTI Breast Cancer Research Group

OTHER

lead

UNICANCER

OTHER

NCT04053322 - Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. | Biotech Hunter | Biotech Hunter