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

NCT04053322 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-03-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Severine GUIU · INSTITUT DE CANCEROLOGIE DE MONTPELLIER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2023-11-15
Completion
2027-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04053322 on ClinicalTrials.gov