368 Participants Needed

Abemaciclib + Fulvestrant for Breast Cancer

(postMONARCH Trial)

Recruiting at 213 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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

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?

The combination of Abemaciclib and Fulvestrant has been shown to be generally safe for treating breast cancer, with common side effects including diarrhea, infections, and low white blood cell counts. These side effects are usually manageable.13678

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

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 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

I am postmenopausal.
I am fully active or restricted in physically strenuous activity but can do light work.
My kidney, blood, and liver functions are all within normal ranges.
See 6 more

Exclusion Criteria

I have undergone multiple treatments for my advanced or metastatic disease.
I have previously been treated with specific hormone or targeted therapies for my cancer.
I have brain metastases that are causing symptoms or have not been treated.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Abemaciclib or placebo in combination with Fulvestrant until discontinuation criteria are met

Up to 22 months
Monthly visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • Abemaciclib
  • Fulvestrant
  • Placebo
Trial OverviewThe study tests if adding abemaciclib to fulvestrant improves outcomes in patients whose breast cancer progressed after previous therapies. Participants will either receive the combination of abemaciclib plus fulvestrant or a placebo plus fulvestrant over up to five years, depending on their response.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Abemaciclib plus FulvestrantExperimental Treatment2 Interventions
Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Group II: Arm B: Placebo plus FulvestrantActive Control2 Interventions
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were 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]
In the MONARCH 2 study, abemaciclib combined with fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS) in patients with hormone receptor positive, HER2-negative advanced breast cancer, showing consistent benefits across both first-line and second-line treatment groups.
The most substantial benefits were seen in patients with primary resistance to endocrine therapy and those with visceral disease, indicating that abemaciclib may be particularly effective for these subgroups.
MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR+, HER2--Advanced Breast Cancer.Neven, P., Johnston, SRD., Toi, M., et al.[2022]
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]

References

Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR+, HER2--Advanced Breast Cancer. [2022]
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. [2021]
MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. [2022]
Abemaciclib: First Global Approval. [2019]
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]
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. [2022]
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. [2023]