Endocrine Therapy + Abemaciclib for Breast Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions a 21-day washout period for those who have received chemotherapy before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Abemaciclib in combination with endocrine therapy for breast cancer?
Research shows that Abemaciclib, when combined with endocrine therapy, significantly reduces the risk of breast cancer recurrence and improves progression-free survival in patients with hormone receptor-positive, HER2-negative breast cancer. This combination has been effective in both early and advanced stages of the disease, providing a valuable treatment option for patients at high risk of recurrence.12345
Is the combination of endocrine therapy and abemaciclib safe for breast cancer treatment?
The combination of endocrine therapy and abemaciclib has been shown to have a tolerable safety profile in breast cancer treatment, with common side effects including diarrhea, infections, and low white blood cell counts (neutropenia). Most side effects were manageable, and the treatment was generally well-tolerated in clinical trials.12346
How is the drug combination of Abemaciclib and endocrine therapy unique for breast cancer treatment?
The combination of Abemaciclib with endocrine therapy is unique because it specifically targets hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, improving outcomes like disease-free survival compared to endocrine therapy alone. Abemaciclib works by inhibiting proteins (CDK4/6) that help cancer cells grow, making it a valuable addition to standard treatments.13457
Research Team
Sarah Sammons, MD
Principal Investigator
Duke University
Eligibility Criteria
This trial is for women over 18 with advanced ER+/HER2- breast cancer who can swallow pills, have good organ function, and can undergo biopsies. They should not be using hormonal birth control or have active cancers (except certain skin cancers), autoimmune diseases, serious infections, or conditions that make biopsy unsafe.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care endocrine therapy and abemaciclib, with changes in tumor immune microenvironment analyzed
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Aromatase Inhibitors
- 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?
Duke University
Lead Sponsor