Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer (NCT02712723)
Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences — Little Rock, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- City of Hope National Medical Center — Duarte, California
- Cancer Research Collaboration — Santa Ana, California
- University of Miami Sylvester Comprehensive Cancer Center — Deerfield Beach, Florida
- University of Kansas Cancer Center - West — Kansas City, Kansas
- University of Kansas Cancer Center - Overland Park — Overland Park, Kansas
- University of Kansas Cancer Center - Westwood — Westwood, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- University of Kansas Cancer Center - South — Kansas City, Missouri
- University of Kansas Cancer Center - North — Kansas City, Missouri
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
- Columbia University Medical Center — New York, New York
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Breast Cancer
- S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer — Anniston, Alabama
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
Explore by condition: All Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.