Trial Summary
What is the purpose of this trial?This trial tests the safety and best dose of two drugs, abemaciclib and niraparib, in patients with a specific type of breast cancer. Abemaciclib blocks proteins needed for cancer cell growth, and niraparib prevents cancer cells from fixing themselves. The goal is to shrink the tumor. Abemaciclib is an orally administered drug approved for treating advanced or metastatic breast cancer.
Eligibility Criteria
This trial is for individuals with hormone receptor positive, HER2 negative breast cancer who haven't had prior cancer treatment (except endocrine therapy) and are planning surgery. They must have satisfactory lab results, agree to use contraception if applicable, not be pregnant or breastfeeding, and can't have certain heart conditions or a history of other cancers within the last 5 years.Inclusion Criteria
I am fully active or can carry out light work.
I had cancer before, was treated with the intent to cure, and have been cancer-free for over 5 years.
I am scheduled for chemotherapy before surgery.
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Exclusion Criteria
My cancer has spread to other parts of my body.
I haven't had any cancer except for certain types in the last 5 years.
I have received treatments like surgery or chemotherapy for my cancer before joining this study.
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Participant Groups
The trial tests the combination of two drugs before surgery: Abemaciclib which blocks proteins needed for cell growth, and Niraparib which prevents tumor cells from repairing DNA damage. The goal is to see how well these work together to shrink tumors in patients with specific types of breast cancer.
1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib, niraparib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID and niraparib PO QD. Treatment repeats every 28 days for up to 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete 4 cycles undergo standard of care mastectomy or lumpectomy. Patients demonstrating progressive disease after only 2 cycles are switched to receive standard of care chemotherapy prior to undergoing mastectomy or lumpectomy.
Abemaciclib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Verzenio for:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
🇪🇺 Approved in European Union as Verzenio for:
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OHSU Knight Cancer InstitutePortland, OR
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Who Is Running the Clinical Trial?
OHSU Knight Cancer InstituteLead Sponsor
GlaxoSmithKlineIndustry Sponsor
Eli Lilly and CompanyIndustry Sponsor
Oregon Health and Science UniversityCollaborator