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Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

NCT02712723 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-03-11

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Letrozole

Nonsteroidal aromatase inhibitor

DRUG

Ribociclib

Oral cyclin-dependent kinase (CDK) inhibitor

DRUG

Placebo

Placebo for ribociclib

Sponsors & Collaborators

Principal Investigators

  • Qamar Khan, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-08-27
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712723 on ClinicalTrials.gov