CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Ribociclib +2 moredrug
Likely dose
Ribociclib 600 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/NCT03078751
NCT03078751Phase 2Completed
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An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

Novartis Pharmaceuticals·interventional·Posted Mar 13, 2017·Updated Oct 11, 2021

In Brief

A Phase 2 clinical trial evaluating Ribociclib, Adjuvant endocrine therapy, and 1 other intervention for Breast Cancer. Completed, enrolled 54 participants across 33 sites.

Detailed Summary

This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartJun 20, 2017
Primary CompletionMar 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.3 years ago

Interventions

Ribociclibdrug

Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth.

Adjuvant endocrine therapydrug

Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days.

Placebodrug

Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth.