234 Participants Needed

Abemaciclib + Tamoxifen for Metastatic Breast Cancer

(Next MONARCH 1 Trial)

Recruiting at 108 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Abemaciclib, when used with other endocrine therapies, has been shown to improve progression-free survival in patients with advanced ER-positive, HER2-negative breast cancer. It is effective as a first-line therapy and in cases where the disease has progressed after initial treatments.12345

Is the combination of Abemaciclib and Tamoxifen safe for treating metastatic breast cancer?

Abemaciclib, when used alone or with other treatments like Tamoxifen, has shown a tolerable safety profile in treating advanced breast cancer. Common side effects include diarrhea, infections, and low white blood cell counts, but these are generally manageable.12367

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

C1

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.
See 6 more

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.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Abemaciclib plus Tamoxifen or Abemaciclib alone, administered orally every 12 hours, with treatment continuing until discontinuation criteria are met

Up to 21 months
Regular visits as per treatment cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Abemaciclib
  • Tamoxifen
Trial Overview The 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.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Verzenio for:
  • Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer
🇪🇺
Approved in European Union as Verzenio for:
  • 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

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

In a phase III trial, abemaciclib combined with endocrine therapy significantly reduced the risk of breast cancer recurrence in patients with hormone receptor positive (HR+), HER2-negative, node-positive early breast cancer, regardless of prior chemotherapy or tumor characteristics.
The combination treatment was generally well-tolerated, with manageable side effects such as diarrhea, infections, and neutropenia, making it a valuable option for high-risk patients.
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence.Fung, S., Blair, HA.[2023]
Interim results from the MONARCH3 study show that abemaciclib, a CDK4/6 inhibitor, is an effective first-line treatment for advanced ER-positive, HER2-negative breast cancer.
Patients receiving abemaciclib in combination with letrozole experienced significantly improved progression-free survival compared to those receiving a placebo with endocrine therapy.
First-Line Abemaciclib Effective in ER+ Breast Cancer.[2019]
Abemaciclib is an oral medication that inhibits cyclin-dependent kinases 4 and 6, specifically approved in the USA for treating advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative.
It is effective both as a combination therapy with fulvestrant for patients who have progressed after endocrine therapy and as a standalone treatment for those who have also undergone chemotherapy, highlighting its role in advanced cancer management.
Abemaciclib: First Global Approval.Kim, ES.[2019]

References

Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]
Abemaciclib: First Global Approval. [2019]
Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer. [2021]
Single-Agent Abemaciclib Active in Breast Cancer. [2019]
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. [2022]
nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer. [2021]
An UHPLC-MS/MS method for quantification of the CDK4/6 inhibitor abemaciclib in human serum. [2022]
Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Abemaciclib: The Newest CDK4/6 Inhibitor for the Treatment of Breast Cancer. [2020]
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