Abemaciclib for Older Patients with Breast Cancer
Trial Summary
What is the purpose of this trial?
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as other investigational therapies, anticancer agents not part of the study, immune-suppressive agents, and herbal medications, at least 7 days before starting the study drug. It's best to discuss your current medications with the trial team to see if any need to be stopped.
What data supports the effectiveness of the drug Abemaciclib for older patients with breast cancer?
Research shows that Abemaciclib, when combined with hormone therapy, reduces the risk of breast cancer coming back in patients with certain types of early breast cancer. It has been effective in both premenopausal and postmenopausal patients, and it helps improve the time patients live without the cancer getting worse.12345
Is Abemaciclib safe for humans?
How is the drug Abemaciclib different from other treatments for breast cancer?
Abemaciclib is unique because it is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, which helps stop cancer cells from growing by blocking specific proteins involved in cell division. It is used in combination with endocrine therapy for patients with hormone receptor-positive, HER2-negative breast cancer, particularly those at high risk of recurrence, and has shown to reduce the risk of cancer returning compared to endocrine therapy alone.23789
Research Team
Joanne E Mortimer, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients aged 70 or older with hormone receptor positive, HER2 negative metastatic breast cancer who have progressed on prior treatments. They must have recovered from previous therapies' side effects and not have certain infections, severe medical conditions, or a history of non-compliance to medical regimens.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
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?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator