Olaparib +/− Atezolizumab for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+59 other locations

Patricia LoRusso, DO < Yale School of ...

Overseen byPatricia M Lorusso

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with non-HER2-positive breast cancer that's locally advanced, unresectable, or metastatic and have a BRCA mutation. They must not be on certain medications, have measurable disease, good organ function, no major surgery within the last 28 days, and agree to use effective contraception.

Inclusion Criteria

My blood clotting tests are within normal limits, or I am on a stable dose of blood thinners.

Ability to understand and the willingness to sign a written informed consent document

I meet the health, organ function, and blood criteria needed to switch from single to combined therapy without full rescreening.

See 35 more

Exclusion Criteria

I do not have brain metastases affecting my participation.

I have autoimmune hypothyroidism and am on a stable thyroid medication dose.

I have type 1 diabetes that is under control with a stable insulin routine.

See 40 more

Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)
Olaparib (PARP Inhibitor)

Trial OverviewThe trial is testing Olaparib alone or combined with Atezolizumab in treating patients. Olaparib blocks enzymes that repair cancer cell DNA while Atezolizumab helps the immune system attack the tumor. The study aims to see which treatment works better.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (olaparib, atezolizumab)Experimental Treatment12 Interventions

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.

Group II: Arm I (olaparib)Experimental Treatment11 Interventions

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: