Abemaciclib + Tamoxifen for Metastatic Breast Cancer
(Next MONARCH 1 Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain cancer therapies, like aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy, at least 14 to 21 days before starting the study treatment.
What data supports the effectiveness of the drug Abemaciclib combined with Tamoxifen for treating metastatic breast cancer?
Is the combination of Abemaciclib and Tamoxifen safe for treating metastatic breast cancer?
How is the drug combination of Abemaciclib and Tamoxifen unique for treating metastatic breast cancer?
The combination of Abemaciclib and Tamoxifen is unique because Abemaciclib is a CDK4/6 inhibitor that targets specific proteins involved in cell division, and when combined with Tamoxifen, a hormone therapy, it offers a novel approach to treating hormone receptor-positive, HER2-negative breast cancer by potentially improving progression-free survival compared to hormone therapy alone.128910
What is the purpose of this trial?
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
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 women with HR+, HER2- metastatic breast cancer who've had at least two chemotherapy regimens, one of which may have been in the metastatic setting. Participants must have recovered from previous treatments, be able to swallow pills, and not be pregnant. They should not have persistent diarrhea or other cancers unless in remission for three years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Abemaciclib plus Tamoxifen or Abemaciclib alone, administered orally every 12 hours, with treatment continuing until discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Tamoxifen
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