A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Public ClinicalTrials.gov record NCT02107703. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02107703
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 669 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2014 (Actual)
- Primary completion
- Feb 14, 2017 (Actual)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- Oct 14, 2026
2014 – 2027
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| University of California - San Diego | La Jolla | California | 92037-0845 | — |
| Kaiser Permanente | Riverside | California | 92505 | — |
| Univ of California San Francisco | San Francisco | California | 94115 | — |
| Stanford University Clinic | Stanford | California | 94305 | — |
| Palm Beach Cancer Institue | Atlantis | Florida | 33462 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| Florida Cancer Specialists - South | Fort Myers | Florida | 33901 | — |
| Palm Beach Cancer Institue | Palm Beach Gardens | Florida | 33410 | — |
| Florida Cancer Specialists - North | St. Petersburg | Florida | 33705 | — |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Tampa | Florida | 33612 | — |
| Palm Beach Cancer Institue | Wellington | Florida | 33414 | — |
| Palm Beach Cancer Institue | West Palm Beach | Florida | 33401 | — |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | — |
| Harbin Clinic | Rome | Georgia | 30165 | — |
| Quincy Medical Group | Quincy | Illinois | 62301 | — |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Breslin Cancer Center | Lansing | Michigan | 48910 | — |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | 55404 | — |
| Washington University Medical School | City of Saint Peters | Missouri | 63376 | — |
| Washington University Medical School | Creve Coeur | Missouri | 63141 | — |
| Freeman Cancer Institute | Joplin | Missouri | 64804 | — |
| St Lukes Hospital | Kansas City | Missouri | 64111 | — |
| Washington University Medical School | St Louis | Missouri | 63110 | — |
| Washington University Medical School | St Louis | Missouri | 63129 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| Rochester General Hospital | Rochester | New York | 14625 | — |
| Novant Health, Oncology Research Institute | Winston-Salem | North Carolina | 27103 | — |
| Oklahoma Cancer Specialists & Research Institute, LLC | Tulsa | Oklahoma | 74146 | — |
| Sanford Research/USD | Sioux Falls | South Dakota | 57104 | — |
| The Boston Baskin Cancer Group | Memphis | Tennessee | 38120 | — |
| SMO Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Oncology Consultants P.A. | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | — |
| St Mary Regional Cancer Center | Walla Walla | Washington | 99362 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02107703, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02107703 live on ClinicalTrials.gov.