Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer
In brief
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.
Key facts
- Study ID
- NCT02712723
- Run by
- Qamar Khan
- People needed
- 121
- Starts
- 2016-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- City of Hope National Medical Center — Duarte, California, United States
- Cancer Research Collaboration — Santa Ana, California, United States
- University of Miami Sylvester Comprehensive Cancer Center — Deerfield Beach, Florida, United States
- University of Kansas Cancer Center - West — Kansas City, Kansas, United States
- University of Kansas Cancer Center - Overland Park — Overland Park, Kansas, United States
- University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Kansas Cancer Center - South — Kansas City, Missouri, United States
- University of Kansas Cancer Center - North — Kansas City, Missouri, United States
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
- Columbia University Medical Center — New York, New York, United States
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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