drugset / Trial / NCT07423611

ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer

NCT07423611

Phase 2 Not yet recruiting 388 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Timeline

Start
2026-10-01
Primary completion
2030-10-01
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified
Comparator Docetaxel Small molecule
Subject Ribociclib Small molecule

Indications