Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Unresectable Breast Carcinoma
• Metastatic Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Biopsy Procedure — PROCEDURE
  Undergo a biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Bone Scan — PROCEDURE
  Undergo a bone scan
• Computed Tomography — PROCEDURE
  Undergo a CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Olaparib — DRUG
  Given PO
• Positron Emission Tomography — PROCEDURE
  Undergo a PET scan
• Questionnaire Administration — OTHER
  Ancillary studies
• X-Ray Imaging — PROCEDURE
  Undergo an x-ray

Study Details

This randomized phase II trial studies how well olaparib with or without atezolizumab work in treating patients with non-HER2-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib with or without atezolizumab will work better in patients with non-HER2-positive breast cancer.

Key Dates

Start date

Mar 30, 2017

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

81 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (olaparib)
  Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to Arm II. Patients undergo an x-ray, CT scan, MRI, bone scan, and/or PET scan as well as a biopsy and blood sample collection throughout the trial. Patients may also undergo a bone marrow aspiration and biopsy on study.
• Experimental: Arm II (olaparib, atezolizumab)
  Patients receive olaparib as in Arm I and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, bone scan, and/or PET scan as well as a biopsy and blood sample collection throughout the trial. Patients may also undergo a bone marrow aspiration and biopsy on study.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Time measured from randomization, assessed up to 7 years ]

Locations (58)

Find similar trials in Phoenix, AZ

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