A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Public ClinicalTrials.gov record NCT03701334. 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 Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).
Study identification
- NCT ID
- NCT03701334
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 5,101 participants
Conditions and interventions
Conditions
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
- Dec 7, 2018 (Actual)
- Primary completion
- May 29, 2030 (Estimated)
- Completion
- May 29, 2030 (Estimated)
- Last update posted
- Oct 9, 2026
2018 – 2030
United States locations
- U.S. sites
- 73
- U.S. states
- 31
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham-Kirklin Clinic | Birmingham | Alabama | 35294-0006 | — |
| Cancer Treatment Centers of America | Goodyear | Arizona | 85338 | — |
| St Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| Comprehensive Blood and Cancer | Bakersfield | California | 93309 | — |
| UCLA Beverly Hills | Beverly Hills | California | 90212 | — |
| UCLA Burbank | Burbank | California | 91505 | — |
| Encino Research Center | Encino | California | 91436 | — |
| St. Jude Heritage Medical Group | Fullerton | California | 92835 | — |
| UCLA Hematology Oncology | Laguna Hills | California | 92653 | — |
| Southern CA Oncology Rsrch Alliance | Los Angeles | California | 90057 | — |
| Stanford University Medical Center | Palo Alto | California | 94304-1509 | — |
| UCLA Pasadena HC Hemato Onco | Pasadena | California | 91105 | — |
| UCLA Porter Ranch Hemato and Onco | Porter Ranch | California | 91326 | — |
| Cancer Care Associates Medical Grp | Redondo Beach | California | 90277 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| UCSF | San Francisco | California | 94115 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| UCLA Santa Monica Hematology Oncology | Santa Monica | California | 90404 | — |
| Lundquist Inst BioMed at Harbor | Torrance | California | 90509-2910 | — |
| UCLA Valencia | Valencia | California | 91355 | — |
| Valley Breast Care | Van Nuys | California | 91405 | — |
| UCLA Cancer Center Westlake Village | Westlake Village | California | 91361 | — |
| University Of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Hospital of Central Connecticut | New Britain | Connecticut | 06052 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | — |
| Holy Cross Hospital-Ft. Lauderdale | Fort Lauderdale | Florida | 33308 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Orlando Health Clinical Trials | Orlando | Florida | 32806 | — |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialists Pan | Tallahassee | Florida | 32308 | — |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Southeastern Regional Medical Center | Newnan | Georgia | 30265 | — |
| Cancer Treatment Centers of America | Zion | Illinois | 60099 | — |
| Cancer Care Center | New Albany | Indiana | 47150 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Fairview Health Services | Maple Grove | Minnesota | 55369 | — |
| Metro Minnesota CCOP | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55416 | — |
| Saint Lukes Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| HCA Midwest Division | Kansas City | Missouri | 64132 | — |
| David C Pratt Cancer Center | St Louis | Missouri | 63141 | — |
| St Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Saint Francis Medical Center | Grand Island | Nebraska | 68803 | — |
| Comprehensive Cancer Cntr Of Nevada | Henderson | Nevada | 89052 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Perlmutter Cancer Centre | New York | New York | 10016 | — |
| Randolph Medical Associates | Asheboro | North Carolina | 27204 | — |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | — |
| Kaiser Permanente NW Region | Clackamas | Oregon | 97015 | — |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | — |
| Cancer Treatment Centers of America Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | — |
| The West Clinic | Germantown | Tennessee | 38138 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Baylor Charles A Sammons Cancer Cnt | Dallas | Texas | 75246 | — |
| Ctr For Cancer And Blood Disorders | Fort Worth | Texas | 76104 | — |
| MD Anderson Cancer Center University of Texas | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Wisconsin Paul P Carbone Comp Cancer Center | 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 314 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03701334, 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 9, 2026 · Synced Oct 26, 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 NCT03701334 live on ClinicalTrials.gov.