Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (NCT04053322) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
France172 participantsStarted 2019-08-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed ER-positive (≥10%), HER2-negative (0, 1+, 2+, and no HER2 gene amplification by ISH), metastatic or locally advanced breast cancer that is not amenable to resection or radiation with curative intent.
✓. Patients aged ≥18 years old (post-menopausal or pre/per-menopausal women and men).
✓. Documented personal germline alteration in BRCA1 or BRCA2 that is predicted to be deleterious. Testing may be performed at any time prior to inclusion.
✓. Patients with a life expectancy ≥16 weeks.
✓. ECOG performance status 0-1.
✓. At least one evaluable lesion, either measurable or non-measurable that can be accurately assessed at baseline by CT-scan or MRI by RECIST v1.1.
✓. Patients could have received 1 line of endocrine therapy (including CDK4/6 inhibitor, but excluding fulvestrant or mTOR inhibitor) and/or 1 line of chemotherapy in the metastatic setting.
✓. Within 28 days prior to administration of study treatment, patients must have adequate organ and bone marrow functions:
Exclusion criteria
✕. Patients without olaparib targetable genomic anomaly identified during the screening phase.
✕. Gene variants (class 1, 2, and 3) of unknown significant prognostic for olaparib sensitivity.
✕. Patients with history of other malignancy except non-melanoma skin cancer, in-situ cancer of the cervix, or solid tumors including lymphomas (without bone marrow involvement) curatively treated and with no evidence of disease for ≥5 years prior to study entry.
✕. Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia.
✕. Patients with symptomatic uncontrolled brain metastases. In addition, treatment of the central nervous system disease must have finished (whole brain radiation, radiosurgery) at least 2 weeks before Cycle 1 Day 1. Patients must not require \>10 mg of prednisone per day or an equivalent dose of other corticosteroids.
✕. Prior treatment with a PARP inhibitor (including olaparib) and/or PD-1 or PD-L1 inhibitor (including durvalumab).
✕. Patients having received anticancer chemotherapy or any other investigational therapy within 3 weeks prior of the study. Endocrine therapy must have been discontinued 7 or more days before Cycle 1 Day 1. Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. Biphosphonates and denosumab are allowed.
✕. Major surgery within 2 weeks prior to registration. Patients must have recovered from earlier major surgery before registration.