Abemaciclib + Niraparib for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you can continue taking corticosteroids if your dose is stable for at least 4 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Abemaciclib and Niraparib for breast cancer?
Niraparib, a part of the drug combination, has shown improved progression-free survival in ovarian cancer patients and is approved for certain ovarian cancers. Additionally, PARP inhibitors like Niraparib have shown potential in breast cancer, especially in patients with specific genetic mutations, suggesting possible benefits in combination therapies.12345
What safety data exists for Abemaciclib and Niraparib in humans?
How is the drug combination of Abemaciclib and Niraparib unique for breast cancer treatment?
The combination of Abemaciclib and Niraparib is unique because it combines a CDK4/6 inhibitor (Abemaciclib) with a PARP inhibitor (Niraparib), potentially offering a novel approach to treating breast cancer by targeting different pathways involved in cancer cell growth and repair, which is different from standard treatments that typically focus on hormone receptor pathways alone.89101112
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.
Research Team
Alexandra Zimmer, M.D.
Principal Investigator
OHSU Knight Cancer Institute
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib and niraparib orally. Treatment repeats every 28 days for up to 2-4 cycles.
Surgery
Participants undergo standard of care mastectomy or lumpectomy after completing treatment cycles.
Follow-up
Participants are monitored for safety and effectiveness after surgery. Follow-up occurs at 30 days post-surgery, every 3 months for the first 6 months, every 6 months for 2 years, then annually for up to 5 years.
Treatment Details
Interventions
- Abemaciclib
- Niraparib Tosylate Monohydrate
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Oregon Health and Science University
Collaborator