Abemaciclib + Niraparib for Breast Cancer

Palo Alto (17 mi)

Dr. Zahi Mitri - Division of Medical ...

Overseen byEvie Hobbs, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Breakthrough Therapy

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 am scheduled for chemotherapy before surgery.

My cancer is positive for estrogen or progesterone receptors.

I agree to have a biopsy for research.

My breast cancer is in an early stage and surgery aims to cure it.

I have breast cancer in one breast with multiple tumors.

I haven't had cancer treatment for my breast cancer, except for hormone therapy.

I can take pills by mouth.

My cancer is not HER2 amplified according to recent guidelines.

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.

I have been diagnosed with inflammatory breast cancer.

I have been diagnosed with MDS/AML or show signs of these conditions.

I cannot have a biopsy or surgery on my breast or lymph nodes due to health risks.

I have been treated with a PARP or CDK 4/6 inhibitor before.

I have a history of lung or blood clot issues.

I have had a surgery to check lymph nodes in my armpit before joining this study.

I do not have any ongoing serious infections.

I am not pregnant or breastfeeding.

Treatment Details

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: