Aromatase Inhibitors + Abemaciclib for Breast Cancer
(MONARCH 3 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving certain treatments like chemotherapy for breast cancer or investigational drugs. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of aromatase inhibitors and abemaciclib for breast cancer?
Research shows that abemaciclib, when combined with endocrine therapy, significantly improves outcomes for patients with hormone receptor-positive, HER2-negative advanced breast cancer, as seen in the MONARCH 2 and 3 trials. Additionally, aromatase inhibitors like letrozole and anastrozole are effective in treating hormone-sensitive metastatic breast cancer, making this combination a promising option.12345
Is the combination of aromatase inhibitors and abemaciclib safe for humans?
How is the drug combination of aromatase inhibitors and Abemaciclib unique for breast cancer treatment?
This treatment combines aromatase inhibitors (which block estrogen production) with Abemaciclib (a drug that inhibits cancer cell growth), offering a novel approach by targeting both hormone production and cell division in breast cancer, potentially improving effectiveness compared to using aromatase inhibitors alone.7891011
What is the purpose of this trial?
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
Research Team
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for postmenopausal women with hormone receptor-positive, HER2-negative breast cancer who can swallow capsules and have either measurable disease or bone-only disease. They should not have received certain prior treatments like everolimus or chemotherapy for advanced breast cancer, nor should they have central nervous system metastasis or be in another conflicting study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 150 mg Abemaciclib or placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Abemaciclib
- Anastrozole
- Letrozole
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?
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