Abemaciclib + Fulvestrant for Breast Cancer
(postMONARCH Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a combination of two drugs, abemaciclib and fulvestrant, for treating a specific type of breast cancer that has not responded to previous treatments. Abemaciclib is taken orally and is approved for treating certain types of breast cancer. The goal is to see if this combination can help stop the cancer from growing. The study may last several years, depending on how well the treatment works for each patient.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have received any systemic therapy between disease recurrence/progression and study screening, or prior treatment with fulvestrant or certain other therapies.
What data supports the effectiveness of the drug combination Abemaciclib and Fulvestrant for breast cancer?
Research shows that the combination of Abemaciclib and Fulvestrant significantly improves progression-free survival and overall survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to Fulvestrant alone. This combination is effective even in patients who have previously received endocrine therapy.12345
Is the combination of Abemaciclib and Fulvestrant safe for treating breast cancer?
How is the drug combination of Abemaciclib and Fulvestrant unique for breast cancer treatment?
The combination of Abemaciclib and Fulvestrant is unique because it significantly improves progression-free survival and overall survival in patients with advanced hormone receptor-positive, HER2-negative breast cancer who have become resistant to endocrine therapy. Abemaciclib is a cyclin-dependent kinase 4 and 6 inhibitor, which helps to stop cancer cells from growing, and when combined with Fulvestrant, it offers a more effective treatment option compared to Fulvestrant alone.14579
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 HR+, HER2- advanced or metastatic breast cancer that worsened after treatment with CDK4/6 inhibitors and endocrine therapy. They must have good organ function, measurable disease progression, be able to take oral medication, and have a performance status of 0 or 1. Women who've had chemotherapy for metastatic breast cancer or certain other treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Abemaciclib or placebo in combination with Fulvestrant until discontinuation criteria are met
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
- Fulvestrant
- Placebo
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