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

  • STATUS
    Recruiting
  • End date
    Feb 2, 2026
  • participants needed
    350
  • sponsor
    Novartis Pharmaceuticals
Updated on 14 July 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (7.1 mi away) Contact
+103 other location
measurable disease
metastasis
advanced breast cancer
HER2
erbb2
aromatase inhibitor
anastrozole
cish
letrozole
mammogram
her2/neu-negative breast cancer
chromogenic in situ hybridization

Summary

QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib (Kisqali Prescribing Information, Investigator Brochure). The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Ribociclib, Goserelin, Letrozole OR Anastrozole
Clinical Study IdentifierNCT03822468
SponsorNovartis Pharmaceuticals
Last Modified on14 July 2021

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