OncoMatch/Clinical Trials/NCT04711824
Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases
Is NCT04711824 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Olaparib and Durvalumab for breast cancer.
Treatment: Olaparib · Durvalumab · Physicians Choice systemic chemotherapy — This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section). Once the subject has recovered from SRS (based on investigator discretion) that will be considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Allowed: BRCA1 any mutation
HER2-negative (with ER/PR expression ≥10% with germline or somatic BRCA mutation
Allowed: BRCA2 any mutation
HER2-negative (with ER/PR expression ≥10% with germline or somatic BRCA mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: combination DDR inhibitor (PARP inhibitor) and immune checkpoint inhibitor
Exception: prior PARP inhibitor without concurrent immune checkpoint inhibitor, or prior immune checkpoint inhibitor without concurrent PARP inhibitor, are allowed
Subjects may have had prior systemic therapy other than combination DDR inhibitor (PARP inhibitor) and immune checkpoint inhibitor (i.e., prior PARP inhibitor without concurrent immune checkpoint inhibitor, or prior immune checkpoint inhibitor without concurrent PARP inhibitor, are allowed)
Cannot have received: whole brain radiation therapy
Subject has had prior whole brain radiation therapy. Prior SRS to brain metastases is allowed as long as previously treated lesions are stable and not planned for further therapy.
Lab requirements
Blood counts
Platelets ≥100 x 10^9/L; ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 10 g/dL with no blood transfusion in the past 28 days
Kidney function
Calculated creatinine clearance ≥ 51 mL/min
Liver function
Bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN unless liver metastases are present in which case ≤ 5x ULN; ALT ≤ 2.5 × ULN unless liver metastases are present in which case ≤ 5x ULN
Cardiac function
INR or PT; aPTT ≤ 1.5 × ULN; patients taking warfarin may participate with careful INR monitoring
Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined in the table below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Memorial Healthcare System · Hollywood, Florida
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
- Memorial Sloan Kettering Cancer Center · New York, New York
- University of North Carolina at Chapel Hill · Chapel Hill, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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