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Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
Sponsor: Fudan University
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1244
Start Date
2025-06-15
Completion Date
2035-05-15
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
Chemotherapy
Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
CDK4/6 Inhibitor
All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)
Endocrine therapy
Endocrine therapy (letrozole/anastrozole/exemestane)