Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Public ClinicalTrials.gov record NCT02278120. 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 Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Study identification
- NCT ID
- NCT02278120
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 672 participants
Conditions and interventions
Conditions
Interventions
- Ribociclib Drug
- Tamoxifen Drug
- Letrozole Drug
- Anastrozole Drug
- Goserelin Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 59 Years
- 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
- Nov 20, 2014 (Actual)
- Primary completion
- Aug 21, 2017 (Actual)
- Completion
- Apr 20, 2023 (Actual)
- Last update posted
- Mar 12, 2024
2014 – 2023
United States locations
- U.S. sites
- 35
- U.S. states
- 24
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Comprehensive Blood and Cancer SC-2 | Bakersfield | California | 93309 | — |
| University Of California Los Angeles Dept of Onc | Los Angeles | California | 90095 | — |
| Comprehensive Cancer Center at Saint Joseph Hospital SC | Denver | Colorado | 80218 | — |
| Danbury Hospital SC | Danbury | Connecticut | 06810 | — |
| Florida Cancer Specialists Onc Dept | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists SC-2 | Fort Myers | Florida | 33901 | — |
| Memorial Cancer Institute SC | Hollywood | Florida | 33021 | — |
| University Of Miami Univ Miami 2 | Miami | Florida | 33136 | — |
| NorthWest Georgia Oncology Centers IRB | Marietta | Georgia | 30060 | — |
| Moanalua Medical Center. Attn: Oncology Dept SC | Honolulu | Hawaii | 96817 | — |
| University of Chicago SC-3 | Chicago | Illinois | 60637 | — |
| Norton Cancer Institute SC | Louisville | Kentucky | 40202 | — |
| Sidney Kimmel CCC At JH Dept of Onc. | Baltimore | Maryland | 21231 | — |
| Massachusetts General Hospital Onc Dept | Boston | Massachusetts | 02114 | — |
| University of Michigan Comprehensive Cancer Center Onc Dept | Ann Arbor | Michigan | 48109 | — |
| Washington Uni School of Med SC | St Louis | Missouri | 63110 | — |
| Meridian Health Systems SC | Neptune City | New Jersey | 07754 | — |
| University of New Mexico Hospital SC-2 | Albuquerque | New Mexico | 87106 | — |
| Clinical Research Alliance . | Lake Success | New York | 11042 | — |
| Duke Univ Medical Center Duke (SC) | Durham | North Carolina | 27710 | — |
| Penn State University Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Bon Secours Cancer Center SC | Greenville | South Carolina | 29607 | — |
| Erlanger Medical Center SC | Chattanooga | Tennessee | 37403 | — |
| SCRI Oncology Partners Tennessee Oncology (3) | Nashville | Tennessee | 37203 | — |
| The Center for Cancer and Blood Disorders SC | Fort Worth | Texas | 76104 | — |
| Methodist Hospita Methodist Can Cen Dept of Oncology | Houston | Texas | 77030 | — |
| Uni of TX MD Anderson Cancer Cntr SC-5 | Houston | Texas | 77030 | — |
| Mays Cancer Ctr Uthsa Mdacc SC-4 | San Antonio | Texas | 78229 | — |
| Brooke Army Medical Center SC | San Antonio | Texas | 78234 | — |
| Northern Utah Cancer Associates | Ogden | Utah | 84403-3105 | — |
| Bon Secours Virginia Health System | Midlothian | Virginia | 23114 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
| Kadlec Clinic Hematology and Onco Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | — |
| Northwest Medical Specialties Dept of Onc | Tacoma | Washington | 98405 | — |
| University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3 | Madison | Wisconsin | 53792-6164 | — |
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 NCT02278120, 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 Mar 12, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02278120 live on ClinicalTrials.gov.