OncRef

Clinical Trial: NCT03822468

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2025-10-16

Study Overview

Brief Summary

The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have received no prior therapy for advanced disease. Premenopausal women were required to receive goserelin in both treatment arms.

Official Title

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Ribociclib
  • Drug: Anastrozole
  • Drug: Letrozole
  • Drug: Goserelin

Other Study ID Numbers

  • CLEE011A2207
  • 2018-004234-15
  • 2018

Start Date (Actual)

2019-06-11

Primary Completion Date (Actual)

2021-06-11

Study Completion Date (Actual)

2024-08-30

Enrollment (Actual)

376

Study Type

Interventional

Phase

Phase 2