drugset / Trial / NCT06996093

Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor

NCT06996093 ↗

Phase 3 Not yet recruiting 2508 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.

Timeline

Start
2025-06-02
Primary completion
2030-06-01
Completion
2034-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified — —
Comparator Docetaxel Small molecule — —

Indications