Combination Therapy for Advanced Breast Cancer
Trial Summary
What is the purpose of this trial?
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have had chemotherapy or radiotherapy within the last 12 months, you may not be eligible. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination therapy for advanced breast cancer?
Research shows that abemaciclib, when combined with other treatments like fulvestrant or letrozole, significantly improves progression-free survival (the time during which the cancer does not get worse) in patients with advanced hormone receptor-positive, HER2-negative breast cancer. This suggests that the combination therapy could be effective in treating advanced breast cancer.12345
Is the combination therapy for advanced breast cancer safe?
The combination therapy involving abemaciclib has been shown to have a tolerable safety profile in clinical trials, with common side effects including diarrhea, infections, and low white blood cell counts. Most side effects were manageable, and the treatment was generally considered safe for patients with advanced breast cancer.12567
How is the drug combination of Abemaciclib, Anastrozole, and Fulvestrant unique for advanced breast cancer?
This drug combination is unique because it includes Abemaciclib, a CDK4/6 inhibitor, which helps stop cancer cells from dividing and growing, and is used alongside Anastrozole and Fulvestrant to improve progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer.12568
Research Team
Rita S. Mehta
Principal Investigator
Chao Family Comprehensive Cancer Center
Eligibility Criteria
This trial is for post-menopausal women with HR+HER2- advanced or metastatic breast cancer, who have relapsed more than a year after prior treatments. Participants must be over 18, in good health with proper organ function, and not currently pregnant. They should agree to contraception if of child-bearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combination therapy with anastrozole, fulvestrant, and abemaciclib
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Anastrozole
- Fulvestrant
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?
University of California, Irvine
Lead Sponsor