drugset
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

NCT03839823 ↗

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
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

Indications

breast cancer