Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Recruiting now · Phase 3
Conditions studied: Early Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT05827081
- Run by
- Novartis Pharmaceuticals
- People needed
- 1400
- Starts
- 2024-02-28
- Expected to finish
- 2030-09-20
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
- Western Reg MC-COH Phoenix — Goodyear, Arizona, United States (enrolling)
- CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (enrolling)
- Onco Inst of Hope and Innovation — Cerritos, California, United States (enrolling)
- City of Hope National Medical — Duarte, California, United States (enrolling)
- Providence Medical Foundation — Fullerton, California, United States (enrolling)
- Los Angeles Cancer Network Good Samaritan — Los Angeles, California, United States (enrolling)
- El Camino Hospital — Mountain View, California, United States (enrolling)
- Palo Alto Medical Foundation — Mountain View, California, United States (enrolling)
- UC Irvine Medical Center — Orange, California, United States (enrolling)
- Sutter Inst Medical Research — Sacramento, California, United States (enrolling)
- School Of Medicine — Sacramento, California, United States (enrolling)
- Sharp Rees Stealy Medical Group Inc — San Diego, California, United States (enrolling)
- AdventHealth Medical Group Hematology and Oncology — Denver, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
- Georgetown University Lombardi Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- AdventHealth Altamonte Springs — Altamonte Springs, Florida, United States (enrolling)
- Holy Cross Health — Fort Lauderdale, Florida, United States (enrolling)
- Hialeah Hospital — Hialeah, Florida, United States (enrolling)
- Memorial Cancer Institute — Hollywood, Florida, United States (enrolling)
- Jupiter Medical Center — Jupiter, Florida, United States (enrolling)
- Ocala Research Institute, Inc — Ocala, Florida, United States (enrolling)
- Central Alabama Research — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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