Abemaciclib + Tamoxifen for Metastatic Breast Cancer
(Next MONARCH 1 Trial)

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

My organs are functioning well.

My breast cancer is hormone receptor positive and HER2 negative.

My condition worsened after hormone therapy.

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Exclusion Criteria

I have a history of fainting, irregular heartbeats, or sudden cardiac arrest.

I have been cancer-free from other types of cancer, except for nonmelanoma skin cancer or in-situ cervical or breast cancer, for at least 3 years.

I do not have an active infection requiring IV antibiotics or a detectable viral infection.

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Treatment Details

Interventions

Abemaciclib (CDK4/6 Inhibitor)
Tamoxifen (Selective Estrogen Receptor Modulator)

Trial OverviewThe study tests the safety and effectiveness of Abemaciclib alone or combined with Tamoxifen versus standard care in women whose breast cancer has progressed after hormone therapy. The goal is to see if these drugs can help control the disease better.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Abemaciclib + TamoxifenExperimental Treatment2 Interventions

Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.

Group II: Abemaciclib + Prophylactic LoperamideExperimental Treatment2 Interventions

Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.

Group III: AbemaciclibExperimental Treatment1 Intervention

Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.