drugset / Trial / NCT03462251

Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line

NCT03462251

Phase 3 Completed 41 enrolled iOMEDICO AG Novartis Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis. Half of the patients will receive a combination of ribociclib and AI/fulvestrant while the other half will receive capecitabine + bevacizumab or paclitaxel +/- bevacizumab.

Timeline

Start
2018-05-24
Primary completion
2021-11-30
Completion
2022-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody
Subject Capecitabine Small molecule
Subject Fulvestrant Small molecule
Subject Paclitaxel Small molecule
Subject Ribociclib Small molecule