Abemaciclib Combination Therapy for Advanced Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing the safety of abemaciclib when used with other treatments for patients whose breast cancer has spread. Abemaciclib helps to stop cancer cells from growing by blocking certain proteins they need. The study aims to find out if this combination is safe for patients with advanced breast cancer.
Will I have to stop taking my current medications?
The trial allows participants to continue certain ongoing therapies, such as letrozole, anastrozole, tamoxifen, exemestane, trastuzumab, and endocrine therapy, depending on the specific part of the study. However, you must stop other previous breast cancer treatments at least 14 to 21 days before starting the trial, except for the ongoing therapies mentioned.
Is abemaciclib safe for humans?
What makes the drug Abemaciclib unique for treating advanced breast cancer?
Abemaciclib is unique because it is an oral medication that specifically targets and inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins involved in cell division, helping to slow down the growth of cancer cells. It is used in combination with endocrine therapy for hormone receptor-positive, HER2-negative advanced breast cancer, and has shown to improve progression-free survival and overall survival compared to endocrine therapy alone.12356
What data supports the effectiveness of the drug Abemaciclib in combination therapy for advanced breast cancer?
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with breast cancer that has spread, who have specific treatment histories and organ function. Participants must not have severe preexisting conditions or certain heart diseases, and should not have received some treatments like CDK4/6 inhibitors (except in Part I) or systemic chemotherapy for metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib in combination with various therapies for metastatic breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Anastrozole
- Endocrine therapy
- Everolimus
- Exemestane
- Fulvestrant
- Letrozole
- Loperamide
- Pertuzumab
- Tamoxifen
- Trastuzumab
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
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Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead 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