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Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
Sponsor: Fudan University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
2508
Start Date
2025-06-02
Completion Date
2034-06-01
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China