Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
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
- 1,444 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 28, 2024 (Actual)
- Primary completion
- Sep 7, 2029 (Estimated)
- Completion
- Sep 20, 2030 (Estimated)
- Last update posted
- Oct 19, 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 | Active, not recruiting |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | Active, not recruiting |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | Active, not 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 | Active, not recruiting |
| Sutter Inst Medical Research | Sacramento | California | 95816-5199 | Active, not recruiting |
| School Of Medicine | Sacramento | California | 95817 | Active, not recruiting |
| Sharp Rees Stealy Medical Group Inc | San Diego | California | 92101 | Recruiting |
| AdventHealth Medical Group Hematology and Oncology | Denver | Colorado | 80210 | Withdrawn |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Active, not recruiting |
| Georgetown University Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007-2197 | Active, not recruiting |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Active, not recruiting |
| AdventHealth Altamonte Springs | Altamonte Springs | Florida | 32701 | Active, not recruiting |
| Holy Cross Health | Fort Lauderdale | Florida | 33308 | Active, not recruiting |
| Hialeah Hospital | Hialeah | Florida | 33013 | Active, not recruiting |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | Recruiting |
| Jupiter Medical Center | Jupiter | Florida | 33458 | Recruiting |
| Ocala Research Institute Inc | Ocala | Florida | 34474 | Active, not recruiting |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | Withdrawn |
| Summit Cancer Care PC | Savannah | Georgia | 31405 | Active, not recruiting |
| Hawaii Cancer Care | Honolulu | Hawaii | 96813 | Withdrawn |
| Affiliated Oncologists IL | Chicago | Illinois | 60415 | Active, not recruiting |
| Hope And Healing Care | Hinsdale | Illinois | 60521 | Recruiting |
| Midwestern Reg MC COH Chicago | Zion | Illinois | 60099 | Active, not recruiting |
| Investigative Clinical R of Indiana | Indianapolis | Indiana | 46260 | Recruiting |
| University of Iowa Health Care | Waukee | Iowa | 50263 | Active, not recruiting |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | Active, not recruiting |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | Active, not recruiting |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | Active, not recruiting |
| Mercy Medical Center | Baltimore | Maryland | 21202 | Recruiting |
| Maryland Oncology Hematology P A | Silver Spring | Maryland | 20904 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02215 | Active, not recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Dana Farber Brigham Women Cancer | Milford | Massachusetts | 01757 | Withdrawn |
| Minnesota Oncology Hematology P A | Minneapolis | Minnesota | 55404 | Active, not recruiting |
| Allina Hlth Cancer Inst Minneapolis | Minneapolis | Minnesota | 55407 | Recruiting |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | Recruiting |
| HCA Midwest Division | Kansas City | Missouri | 64132 | Active, not recruiting |
| WA Uni School Of Med | St Louis | Missouri | 63110 | Active, not recruiting |
| Intermountain Healthcare | Billings | Montana | 59102 | Active, not recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68154 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Active, not recruiting |
| Cancer Care Specialists | Reno | Nevada | 89511 | Active, not recruiting |
| MD Anderson Cancer Center At Cooper | Camden | New Jersey | 08103 | Active, not recruiting |
| Summit Health | Florham Park | New Jersey | 07932 | Active, not recruiting |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | Active, not recruiting |
| Presbyterian Medical Group | Albuquerque | New Mexico | 87110 | Active, not recruiting |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | Active, not recruiting |
| Optum Health | Lake Success | New York | 11042 | Active, not 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 | Active, not recruiting |
| Good Samaritan Regional Medical Center | Corvallis | Oregon | 97330 | Active, not 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 | Active, not recruiting |
| Univ of Pittsburg Med Ctr Pinnacle | Harrisburg | Pennsylvania | 17109 | Active, not recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Active, not 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 | Active, not recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Recruiting |
| El Paso Texas Oncology | El Paso | Texas | 79902 | Active, not recruiting |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | Active, not recruiting |
| University of Texas | Houston | Texas | 77030-4099 | Recruiting |
| Texas Oncology P A Plano East | Plano | Texas | 75075 | Active, not recruiting |
| Texas Oncology PA Tyler | Tyler | Texas | 75702 | Active, not recruiting |
| Bon Secours Virginia Health System | Midlothian | Virginia | 23114 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Active, not recruiting |
| Kadlec Clinic Hematology and Onco | Kennewick | Washington | 99336 | Active, not recruiting |
| Providence Regional Cancer System | Lacey | Washington | 98503 | Active, not recruiting |
| Valley Medical Center Research | Renton | Washington | 98055 | Active, not recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Active, not recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Active, not 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 144 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 Oct 19, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05827081 live on ClinicalTrials.gov.