At a glance
ClinicalIndex Comparison RecordPhase 2Active· 121 enrolled
Drug / intervention
Letrozole +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Letrozole, Ribociclib, and 1 other intervention for Breast Cancer. Active but no longer recruiting, targeting 121 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 2Active
201620172018201920202021202220232024202520262027
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionAug 2018
TodayJul 2026
Study CompletionDec 2026
First PostedMar 18, 2016
Enrollment StartFeb 1, 2016
Primary CompletionAug 27, 2018
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.3 years ago
Interventions
Letrozoledrug
Nonsteroidal aromatase inhibitor
Ribociclibdrug
Oral cyclin-dependent kinase (CDK) inhibitor
Placebodrug
Placebo for ribociclib