Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
Public ClinicalTrials.gov record NCT02422615. 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
A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
Study identification
- NCT ID
- NCT02422615
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 726 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Jun 9, 2015 (Actual)
- Primary completion
- Nov 3, 2017 (Actual)
- Completion
- Jan 11, 2023 (Actual)
- Last update posted
- Nov 30, 2023
2015 – 2023
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center PC SC-2 | Mobile | Alabama | 36608 | — |
| Ironwood Cancer and Research Centers SC-2 | Chandler | Arizona | 85224 | — |
| Highlands Oncology Group . | Fayetteville | Arkansas | 72703 | — |
| UCLA Medical Center . | Los Angeles | California | 90095 | — |
| Central Coast Medical Oncology Corporation SC | Santa Maria | California | 93454 | — |
| St Joseph Heritage Healthcare | Santa Rosa | California | 94503 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80528 | — |
| Florida Cancer Research Institute Dept of Oncology | Davie | Florida | 33328 | — |
| Florida Hospital Cancer Institute SC | Orlando | Florida | 32804 | — |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| John D Archbold Memorial Hospital Main | Thomasville | Georgia | 31792 | — |
| Moanalua Medical Center. Attn: Oncology Dept SC | Honolulu | Hawaii | 96817 | — |
| Oncology Specialists, SC Advocate Medical Group-Niles | Park Ridge | Illinois | 60068-0736 | — |
| Jackson Oncology Associates SC | Jackson | Mississippi | 39202 | — |
| Meridian Health Systems Regulatory | Neptune City | New Jersey | 07753 | — |
| University of New Mexico Cancer Center SC | Albuquerque | New Mexico | 87131 | — |
| CR Wood Cancer Center SC | Glens Falls | New York | 12801 | — |
| Clinical Research Alliance . | Lake Success | New York | 11042 | — |
| NYU Langone Med Center CV Research NYU Langone Medical Center | New York | New York | 10016 | — |
| Genesis Cancer Services SC | Zanesville | Ohio | 43701 | — |
| Penn State University Milton S Hershey Medical Center SC | Hershey | Pennsylvania | 17033 | — |
| Millennium Research Clin Develop SC | Houston | Texas | 77090 | — |
| Northern Utah Cancer Associates CFTY720DUS01 | Ogden | Utah | 84403-3105 | — |
| Providence Regional Cancer Partnership . | Everett | Washington | 98201 | — |
| Providence Regional Cancer System SC | Lacey | Washington | 98503 | — |
| Virginia Mason Medical Center-Oncology SC | Seattle | Washington | 98101 | — |
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 148 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02422615, 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 Nov 30, 2023 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02422615 live on ClinicalTrials.gov.