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~6 spots leftby Aug 2025

Olaparib +/− Atezolizumab for Advanced Breast Cancer

Palo Alto (17 mi)

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 tests do not show signs of MDS or AML.

I am on a stable HIV medication regimen.

I have a tumor that can be measured with imaging or physical exam.

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

My kidneys are functioning well.

My LH and FSH levels indicate I am post-menopausal, even though I am under 50.

I had my ovaries removed due to radiation and my last period was over a year ago.

I can take pills and don't have vomiting or stomach issues that affect medication absorption.

I have had surgery to remove my ovaries or uterus.

Exclusion Criteria

I do not have brain metastases affecting my participation.

I have previously been treated with PARP inhibitors or anti-PD-1/PD-L1 antibodies.

My condition is stable with mild steroid creams.

I haven't had a severe flare-up of my condition requiring strong treatments in the past year.

I haven't had major surgery in the last 28 days and don't expect to need one during the study.

I have not received a live flu vaccine within the last 4 weeks.

I have not had uncontrolled seizures or any seizures in the past year.

My heart's electrical activity (QTc) is over 470 msec, or I have a family history of long QT syndrome.

I am not using strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.

I am not using strong or moderate drugs that affect drug metabolism.

I have not had a severe infection or been hospitalized for one in the last 4 weeks.

I have a significant liver condition, such as hepatitis or cirrhosis.

I have not received a live vaccine in the last 4 weeks and do not plan to during or up to 5 months after the study.

I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.

I am not pregnant or breastfeeding.

My brain scans improved after treatment and showed no worsening before my screening.

My cancer can be measured or seen outside the brain and spinal cord.

I tested positive for hepatitis C but have no active virus according to my PCR test.

My cancer has not spread to specific parts of my brain or close to my optic nerves.

I do not have any serious health issues that are not under control.

I have had severe side effects from previous immunotherapy.

My rash covers less than 10% of my body.

I have never had bleeding in my spinal cord.

Treatment Details

The 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.

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: