NCT07005557

Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer

Study Evaluating Node-positive, ER+/HER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,244 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.

Conditions

• Breast Cancer
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	Chemotherapy	Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
DRUG	CDK4/6 Inhibitor	All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)
DRUG	Endocrine therapy	Endocrine therapy (letrozole/anastrozole/exemestane)

Timeline

• Start date: 2025-06-15
• Primary completion: 2030-05-15
• Completion: 2035-05-15
• First posted: 2025-06-05
• Last updated: 2025-06-05