MedTrace Logo

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

NCT03822468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2025-10-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Ribociclib

Ribociclib (at a dosage of 400 mg or 600 mg) QD orally taken on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (days 22 to 28). Ribociclib was supplied as 200 mg tablets as individual patient supply packaged bottles.

DRUG

Anastrozole

Anastrozole 1 mg tablets for oral use QD continuously

DRUG

Letrozole

Letrozole 2.5 mg tablets for oral use QD continuously

DRUG

Goserelin

Goserelin 3.6 mg subcutaneously once every 4 weeks (pre-menopausal women only)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2021-06-11
Completion
2024-08-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Costa Rica
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Jordan
  • Lithuania
  • Peru
  • Portugal
  • Russia
  • South Africa
  • Sweden
  • Thailand

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 NCT03822468 on ClinicalTrials.gov