Evaluate the Benefit of Adding ART6043 to Olaparib for HER2-Negative Metastatic or Advanced Breast Cancer and a gBRCA Mutation (POLKA)

About the Study

This study is evaluating the addition of ART6043, a novel targeted therapy, to olaparib, a standard treatment, in adults with HER2-negative advanced or metastatic breast cancer and an inherited gBRCA mutation. The study will compare ART6043 plus olaparib with olaparib alone to better understand the potential benefits and risks of treatment.

What the Study Involves

This is a Phase 2, open-label, randomized clinical trial.

People who join the study will:

• Have screening tests to see if they are eligible
• Be assigned to receive either the targeted therapy ART6043 plus the PARP inhibitor olaparib or olaparib alone.
• Take the study medicines as tablets twice a day in 21-day cycles.
• Have regular clinic visits for physical examinations, ECGs, and CT or MRI scans.
• Provide a tumor tissue sample from a prior biopsy or have a tumor biopsy if enough stored tumor tissue is not available.
• Provide blood and urine samples during the study.
• Continue study treatment unless their cancer gets worse, they have side effects that are not acceptable, or they choose to stop participating in the study.

Participants may receive reimbursement for reasonable travel expenses incurred while on the study.

Lead Researchers/Study PIs and Affiliation

Mark Robson, Memorial Sloan Kettering

• You are 18 years of age or older
• You have HER2-negative, locally advanced or metastatic breast cancer
• You have an inherited BRCA mutation.
• You have received less than 1 month’s treatment with a PARP inhibitor (such as olaparib)
• You have previously received treatment for your breast cancer and may be eligible for treatment with a PARP inhibitor and your cancer did not worsen while receiving previous treatment with a PARP inhibitor. 
• You can provide a tumor tissue sample or are willing to undergo a tumor biopsy if needed for the study.
   

• You have significant heart disease or reduced heart function. 
• You have active or uncontrolled brain metastasis.
• You have inflammatory breast cancer.
• You have myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or findings that may suggest MDS or AML. 
• You have ongoing interstitial lung disease or pneumonitis.