Abemaciclib + Fulvestrant for Breast Cancer
(MONARCH 2 Trial)

Recruiting in Palo Alto (17 mi)

+267 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Eligibility Criteria

This trial is for postmenopausal women with HR+, HER2- advanced breast cancer who haven't had more than one endocrine therapy or any chemo for metastatic disease. They must have a good performance status, no central nervous system metastasis, and not be in another conflicting study.

Inclusion Criteria

I have never received hormone therapy for my current or any previous cancer.

I am not pregnant and agree to use birth control during and 12 weeks after the study if my menopause is due to treatment.

My cancer can be measured by tests or is only in my bones.

+6 more

Exclusion Criteria

I have not taken any experimental drugs recently.

I recently got a yellow fever vaccine.

I have had heart problems in the last year.

+9 more

Participant Groups

The study tests if adding Abemaciclib to Fulvestrant improves progression-free survival compared to Fulvestrant alone in these patients. Participants are randomly assigned to receive either the combination or just Fulvestrant over about 9 months.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Abemaciclib + FulvestrantExperimental Treatment2 Interventions

Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg 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 were met.

Group II: Placebo + FulvestrantPlacebo Group2 Interventions

Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation 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: