Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF)
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|ClinicalTrials.gov Identifier: NCT04053322|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : November 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Durvalumab Drug: Olaparib Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||August 2027|
|Experimental: Study Arm||
Durvalumab will start 4 weeks after the first dose of olaparib (Cycle 2, Day 1) at 1500 mg intravenous (IV) every 4 weeks.
2 x 150 mg tablets taken in the morning and in the evening orally (2 X 300 mg daily)
Two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15, and then Day 1 of each subsequent 28-day cycle.
- Progression-free survival rate (PFSR) [ Time Frame: 24 weeks ]The progression-free survival rate at 24 weeks defined as the percentage of patients alive without disease progression at 24 weeks after inclusion. PFSR will be evaluated by local investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). The death of a patient for any cause within 24 weeks will be considered as failure
- The incidence of adverse events (Safety) [ Time Frame: 6 years ]Adverse events will be graded using NCI-CTCAE v5.0
- Overall Survival (OS) [ Time Frame: 6 years ]OS is defined as the interval between the date of inclusion and the date of death from any cause. A patient alive will be censored at the last date of follow-up
- Objective response rate (ORR) [ Time Frame: 3 years ]The ORR defined as the percent of patients with a complete response (CR) or a partial response (PR).
- Duration of response (DoR). [ Time Frame: 3 years ]The DoR defined as the duration between the time measurement criteria are first met for CR or PR until the first date that recurrent disease is objectively documented
- Progression-free survival (PFS) [ Time Frame: 6 years ]PFS defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053322
|Contact: Clara GUYONNEAU||+33 (0) 1 44 23 55 firstname.lastname@example.org|
|Institut de Cancerologie de Montpellier||Recruiting|
|Montpellier, France, 34000|
|Contact: Severine Guiu|
|Rouen, France, 76000|
|Contact: Isabelle TENNEVET|
|Principal Investigator:||Severine GUIU||INSTITUT DE CANCEROLOGIE DE MONTPELLIER|