Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Public ClinicalTrials.gov record NCT02941926. 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
COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..
Study identification
- NCT ID
- NCT02941926
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,246 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
- Nov 30, 2016 (Actual)
- Primary completion
- Nov 8, 2019 (Actual)
- Completion
- Nov 9, 2022 (Actual)
- Last update posted
- Oct 24, 2023
2016 – 2022
United States locations
- U.S. sites
- 71
- U.S. states
- 31
- U.S. cities
- 69
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Cancer Research and Education Center | Anchorage | Alaska | 99508 | — |
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates | Phoenix | Arizona | 85016 | — |
| Arizona Oncology Associates Arizona Oncology Assoc. (2) | Tucson | Arizona | 85745 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| Pacific Shores Medical Group SC | Long Beach | California | 90813 | — |
| USC Norris Cancer Center | Los Angeles | California | 90033 | — |
| University of California Irvine UC Irvine (11) | Orange | California | 92868 | — |
| Ventura County Hematology and Oncology | Oxnard | California | 93030 | — |
| PCR Oncology | Pismo Beach | California | 93449 | — |
| California Pacific Medical Center Onc Dept | San Francisco | California | 94120-7999 | — |
| Centura Health Research Center Centura Health Research Center | Denver | Colorado | 80210 | — |
| Poudre Valley Hospital Poudre Valley Health System | Fort Collins | Colorado | 80528 | — |
| Valley View Hospital Cancer Center | Glenwood Springs | Colorado | 81601 | — |
| Florida Cancer Research Institute Dept of Oncology | Davie | Florida | 33328 | — |
| Foundation for Sickle Cell Disease Research | Hollywood | Florida | 33021 | — |
| Watson Clinic Center for Research 1730 Location | Lakeland | Florida | 33805 | — |
| Mid Florida Hematology and Onc Ctr | Orange | Florida | 32763 | — |
| Summit Cancer Care Summit Cancer Care (SC) | Savannah | Georgia | 31405 | — |
| John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4) | Thomasville | Georgia | 31792 | — |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| Stroger Cook County Hospital Division of Hematology & Onc | Chicago | Illinois | 60612 | — |
| Joliet Oncology-Hematology Associates Presence Cancer Center | Joliet | Illinois | 60435 | — |
| Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3) | Normal | Illinois | 61761 | — |
| Alpha Med Physician Group, LLC | Tinley Park | Illinois | 60487 | — |
| Indian Univ Health Goshen Center forCancer SC | Goshen | Indiana | 46526 | — |
| Northwest Oncology | Munster | Indiana | 46321 | — |
| June E. Nylan Cancer Center | Sioux City | Iowa | 51101 | — |
| University of Kansas Medical Center University of Kansas Med Ctr 9 | Kansas City | Kansas | 66160-7330 | — |
| Sarah Cannon at Overland Park Regional Medical Center | Overland Park | Kansas | 66209 | — |
| John Ochsner Heart and Vascular Institute Clinical Trials | New Orleans | Louisiana | 70121 | — |
| Northern Light Mercy Hospital SC | Portland | Maine | 04102 | — |
| Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr | Baltimore | Maryland | 21204-6831 | — |
| Maryland Oncology Hematology P A Columbia | Rockville | Maryland | 20850 | — |
| Kaiser Permanente | Rockville | Maryland | 20879 | — |
| Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2 | Washington DC | Maryland | 20037 | — |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | — |
| Nebraska Hematology-Oncology, P.C. | Lincoln | Nebraska | 68506 | — |
| Nebraska Cancer Specialists Oncology Hematology West | Omaha | Nebraska | 68154 | — |
| Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4) | Henderson | Nevada | 89052 | — |
| Trinitas Comprehensive Cancer Center | Elizabeth | New Jersey | 07207 | — |
| Englewood Health | Englewood | New Jersey | 07631 | — |
| The Valley Hospital / Luckow Pavillion | Paramus | New Jersey | 07652 | — |
| Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI | Somerset | New Jersey | 08873 | — |
| New Mexico Cancer Care Alliance . | Albuquerque | New Mexico | 87106 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Clinical Research Alliance | Lake Success | New York | 11042 | — |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | — |
| Oncology Speciialists of Charlotte | Charlotte | North Carolina | 28207 | — |
| Aultman Cancer Center Main Centre | Canton | Ohio | 44710 | — |
| The Christ Hospital Cancer Center Research Program Linder Research Center | Cincinnati | Ohio | 45219 | — |
| University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation Cleveland Clinic (5) | Cleveland | Ohio | 44195 | — |
| Dayton Physicians | Kettering | Ohio | 45409 | — |
| Oklahoma Cancer Specialists and Research Institute SC-2 | Tulsa | Oklahoma | 74136 | — |
| Oregon Health Sciences University SC-5 | Portland | Oregon | 97239 | — |
| McLeod Center for Cancer Treatment and Research | Florence | South Carolina | 29506 | — |
| Carolina Blood and Cancer Care of South Carolina | Rock Hill | South Carolina | 29732 | — |
| Millennium Research Clin Develop Millennium Oncology - FL | Houston | Texas | 77090 | — |
| Mays Cancer Ctr Uthsa Mdacc | San Antonio | Texas | 78229 | — |
| Hope Cancer Center of East Texas | Tyler | Texas | 75701 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| PeaceHealth St Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Providence Regional Medical Centre of Everett | Everett | Washington | 98201 | — |
| Kadlec Clinic Hematology and Onco | Kennewick | Washington | 99336 | — |
| Valley Medical Center Research Valley Medical Center | Renton | Washington | 98055 | — |
| Virginia Mason Medical Center-Oncology SC | Seattle | Washington | 98101 | — |
| Northwest Medical Specialties Dept.ofNW Med. Specialties | Tacoma | Washington | 98405 | — |
| Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee | Milwaukee | Wisconsin | 53211 | — |
| Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3) | Cheyenne | Wyoming | 82001 | — |
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 424 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02941926, 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 24, 2023 · Synced Oct 30, 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 NCT02941926 live on ClinicalTrials.gov.