ClinicalTrials.gov record
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
ClinicalTrials.gov ID: NCT05827081
Public ClinicalTrials.gov record NCT05827081. 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 IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Study identification
- NCT ID
- NCT05827081
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,400 participants
Conditions and interventions
Conditions
Interventions
- Ribociclib Drug
- Letrozole Drug
- Ansastrozole Drug
- Goserelin Drug
- Leuprolide Drug
- Exemestane Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- 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
- Feb 27, 2024
- Primary completion
- Sep 6, 2029
- Completion
- Sep 19, 2030
- Last update posted
- Aug 31, 2026
2024 – 2030
United States locations
- U.S. sites
- 85
- U.S. states
- 38
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | Recruiting |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | Recruiting |
| Western Reg MC-COH Phoenix | Goodyear | Arizona | 85338 | Recruiting |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | Recruiting |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | Recruiting |
| Onco Inst of Hope and Innovation | Cerritos | California | 90703 | Recruiting |
| City of Hope National Medical | Duarte | California | 91010 | Recruiting |
| Providence Medical Foundation | Fullerton | California | 92835 | Recruiting |
| Los Angeles Cancer Network Good Samaritan | Los Angeles | California | 90017 | Recruiting |
| El Camino Hospital | Mountain View | California | 94040 | Recruiting |
| Palo Alto Medical Foundation | Mountain View | California | 94040 | Recruiting |
| UC Irvine Medical Center | Orange | California | 92868 | Recruiting |
| Sutter Inst Medical Research | Sacramento | California | 95816-5199 | Recruiting |
| School Of Medicine | Sacramento | California | 95817 | Recruiting |
| Sharp Rees Stealy Medical Group Inc | San Diego | California | 92101 | Recruiting |
| AdventHealth Medical Group Hematology and Oncology | Denver | Colorado | 80210 | Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Recruiting |
| Georgetown University Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007-2197 | Recruiting |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| AdventHealth Altamonte Springs | Altamonte Springs | Florida | 32701 | Recruiting |
| Holy Cross Health | Fort Lauderdale | Florida | 33308 | Recruiting |
| Hialeah Hospital | Hialeah | Florida | 33013 | Recruiting |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | Recruiting |
| Jupiter Medical Center | Jupiter | Florida | 33458 | Recruiting |
| Ocala Research Institute, Inc | Ocala | Florida | 34474 | Recruiting |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | Recruiting |
| Summit Cancer Care PC | Savannah | Georgia | 31405 | Recruiting |
| Hawaii Cancer Care | Honolulu | Hawaii | 96813 | Recruiting |
| Affiliated Oncologists IL | Chicago | Illinois | 60415 | Recruiting |
| Hope And Healing Care | Hinsdale | Illinois | 60521 | Recruiting |
| Midwestern Reg MC COH Chicago | Zion | Illinois | 60099 | Recruiting |
| Investigative Clinical R of Indiana | Indianapolis | Indiana | 46260 | Recruiting |
| University of Iowa Health Care | Waukee | Iowa | 50263 | Recruiting |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | Recruiting |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | Recruiting |
| Mercy Medical Center | Baltimore | Maryland | 21202 | Recruiting |
| Maryland Oncology Hematology P A | Silver Spring | Maryland | 20904 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02118 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Dana Farber Brigham Women Cancer | Milford | Massachusetts | 01757 | Recruiting |
| Minnesota Oncology Hematology P A | Minneapolis | Minnesota | 55404 | Recruiting |
| Allina Hlth Cancer Inst Minneapolis | Minneapolis | Minnesota | 55407 | Recruiting |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | Recruiting |
| HCA Midwest Division | Kansas City | Missouri | 64132 | Recruiting |
| WA Uni School Of Med | St Louis | Missouri | 63110 | Recruiting |
| Intermountain Healthcare | Billings | Montana | 59102 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68154 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Recruiting |
| Cancer Care Specialists | Reno | Nevada | 89511 | Recruiting |
| MD Anderson Cancer Center At Cooper | Camden | New Jersey | 08103 | Recruiting |
| Summit Health | Florham Park | New Jersey | 07932 | Recruiting |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | Recruiting |
| Presbyterian Medical Group | Albuquerque | New Mexico | 87110 | Recruiting |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | Recruiting |
| Optum Health | Lake Success | New York | 11042 | Recruiting |
| Mount Sinai School of Medicine | New York | New York | 10029 | Recruiting |
| Duke Cancer Network | Durham | North Carolina | 27710 | Recruiting |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | Recruiting |
| Sanford Research USD Fargo | Fargo | North Dakota | 58122 | Recruiting |
| Good Samaritan Regional Medical Center | Corvallis | Oregon | 97330 | Recruiting |
| Oncology Associates of Oregon PC | Eugene | Oregon | 97401-8122 | Recruiting |
| Northwest Cancer Specialists | Portland | Oregon | 97210 | Recruiting |
| Oregon Oncology Specialists Salem | Salem | Oregon | 97301 | Recruiting |
| Consultants In Med Onco And Hema | Drexel Hill | Pennsylvania | 19026 | Recruiting |
| Univ of Pittsburg Med Ctr Pinnacle | Harrisburg | Pennsylvania | 17109 | Recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Bon Secours St Francis Cancer Center | Greenville | South Carolina | 29607 | Recruiting |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | Withdrawn |
| Regional Medical Oncology NC | Wilson | South Carolina | 27893 | Withdrawn |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57104 | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Recruiting |
| El Paso Texas Oncology | El Paso | Texas | 79902 | Recruiting |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | Recruiting |
| University of Texas | Houston | Texas | 77030-4099 | Recruiting |
| Texas Oncology P A Plano East | Plano | Texas | 75075 | Recruiting |
| Texas Oncology PA Tyler | Tyler | Texas | 75702 | Recruiting |
| Bon Secours Virginia Health System | Midlothian | Virginia | 23114 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
| Kadlec Clinic Hematology and Onco | Kennewick | Washington | 99336 | Recruiting |
| Providence Regional Cancer System | Lacey | Washington | 98503 | Recruiting |
| Valley Medical Center Research | Renton | Washington | 98055 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
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 143 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05827081, 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 Aug 31, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05827081 live on ClinicalTrials.gov.