Abemaciclib for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies how well abemaciclib works in patients with triple negative breast cancer that can be surgically removed but does not respond to chemotherapy. Abemaciclib is a pill that may help stop cancer cell growth by blocking certain enzymes. The trial includes patients who receive different treatments before surgery.
Will I have to stop taking my current medications?
The trial requires participants to stop using strong and moderate inducers or strong inhibitors of cytochrome P450 3A at least 7 days before registration. If you are taking these types of medications, you will need to stop them before joining the trial.
Is Abemaciclib safe for humans?
How is the drug Abemaciclib unique for treating triple-negative breast cancer?
Abemaciclib is unique because it is a CDK4/6 inhibitor that targets the cell cycle, and while it is primarily used for ER-positive breast cancer, research suggests it may also be effective in a subset of triple-negative breast cancer when combined with other treatments, like androgen receptor-targeted agents.12367
Who Is on the Research Team?
Matthew P. Goetz
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older with triple negative breast cancer that remains after chemotherapy and can be surgically removed. Participants must not be pregnant, should have completed chemo within the last 56 days, and cannot use certain drugs affecting liver enzymes. They must also provide tissue samples, swallow pills, and have no other active cancers or serious medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Patients receive a neoadjuvant chemotherapy regimen, with or without pembrolizumab, to assess chemotherapy resistance.
Treatment with Abemaciclib
Patients receive abemaciclib orally twice daily for 14-21 days, followed by surgical resection.
Surgical Resection
Patients undergo standard of care surgical resection after completion of abemaciclib treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of CD8/FOXP3 ratio and other biomarkers.
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
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?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator