drugset / Trial / NCT03839823

Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

Phase 2 Completed 222 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer

Timeline

Start: 2019-02-25
Primary completion: 2022-04-12
Completion: 2023-05-10

Outcome

Met primary endpoint

registry analysis (superiority test); Ribociclib 600 mg vs Combination Chemotherapy; p = 0.003; Hazard Ratio (HR) 0.611 (95% CI 0.429 to 0.870); one-sided stratified logrank test NCT03839823 ↗

Publications

Lu YS, Mahidin EIBM, Azim H, Eralp Y, Yap YS, Im SA, Rihani J, Gokmen E, El Bastawisy A, Karadurmus N, Lim YN, Lim CS, Duc LT, Chung WP, Babu KG, Penkov K, Bowles J, Alfaro TD, Wu J, Gao M, Slimane K, El Saghir NS. Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. J Clin Oncol. 2024 Aug 10;42(23):2812-2821. doi: 10.1200/JCO.24.00144. Epub 2024 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	Capecitabine	Small molecule	1600 mg/m2	Oral
Subject	Capecitabine	Small molecule	2500 mg/m2	Oral
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Subject	Goserelin	Other / unclassified	3.6 mg	Subcutaneous
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	90 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	175 mg/m2	Intravenous
Subject	Ribociclib	Small molecule	600 mg	Oral
Subject	Vinorelbine	Small molecule	25 mg/m2	Oral
Subject	Vinorelbine	Small molecule	30 mg/m2	Oral
Subject	Vinorelbine	Small molecule	60 mg/m2	Oral
Subject	Vinorelbine	Small molecule	80 mg/m2	Oral