CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 5,101 enrolled
Drug / intervention
Ribociclib +1 moredrug
Likely dose
Ribociclib 400 mgfrom 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.

Search/NCT03701334
NCT03701334Phase 3Active
CompareCT.gov

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Novartis Pharmaceuticals·interventional·Posted Oct 10, 2018·Updated Apr 1, 2026

In Brief

A Phase 3 clinical trial evaluating Ribociclib and Endocrine Therapy (ET) for Early Breast Cancer. Active but no longer recruiting, targeting 5,101 participants across 387 sites in 20 countries.

Detailed Summary

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Breast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsTranslational Research in Oncology

Timeline

Phase 3Active
201920202021202220232024202520262027202820292030
First PostedOct 10, 2018
Enrollment StartDec 7, 2018
Primary CompletionMay 29, 2030
TodayJul 2, 2026
Enrollment to primary: 11.5 yearsPosted 7.7 years agoPrimary completion in 3.9 years

Interventions

Ribociclibdrug

Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Endocrine Therapy (ET)other

Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information