πŸ›οΈ Verified NIH Record β€’ Updated 2025-10-17

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (NCT02107703)

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

πŸ”΅ Active, Not Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: Eli Lilly and Company

🩺 Plain-English Summary (8th-Grade Level)

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 naΓ―ve cohort, all participants will received abemaciclib + fulvestrant.

Who can join: Review the eligibility criteria below.

Location: St. Bernards Medical Center β€” Jonesboro, Arkansas

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (146 Sites)

Showing the first 25 of 146 sites.

  • St. Bernards Medical Center β€” Jonesboro, Arkansas
  • Highlands Oncology Group β€” Springdale, Arkansas
  • University of California - San Diego β€” La Jolla, California
  • Kaiser Permanente β€” Riverside, California
  • Univ of California San Francisco β€” San Francisco, California
  • Stanford University Clinic β€” Stanford, California
  • Palm Beach Cancer Institue β€” Atlantis, Florida
  • Holy Cross Hospital β€” Fort Lauderdale, Florida
  • Florida Cancer Specialists - South β€” Fort Myers, Florida
  • Palm Beach Cancer Institue β€” Palm Beach Gardens, Florida
  • Florida Cancer Specialists - North β€” St. Petersburg, Florida
  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center β€” Tampa, Florida
  • Palm Beach Cancer Institue β€” Wellington, Florida
  • Palm Beach Cancer Institue β€” West Palm Beach, Florida
  • University Cancer & Blood Center, LLC β€” Athens, Georgia
  • Harbin Clinic β€” Rome, Georgia
  • Quincy Medical Group β€” Quincy, Illinois
  • Pharmasite Research, Inc. β€” Baltimore, Maryland
  • Dana Farber Cancer Institute β€” Boston, Massachusetts
  • Breslin Cancer Center β€” Lansing, Michigan
  • Minnesota Oncology/Hematology PA β€” Minneapolis, Minnesota
  • Washington University Medical School β€” City of Saint Peters, Missouri
  • Washington University Medical School β€” Creve Coeur, Missouri
  • Freeman Cancer Institute β€” Joplin, Missouri
  • St Lukes Hospital β€” Kansas City, Missouri

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Neoplasms clinical trials

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—