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Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Official title: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1163
Start Date
2023-11-17
Completion Date
2029-06
Last Updated
2024-04-02
Healthy Volunteers
No
Conditions
Interventions
Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Endocrine therapy
Fulvestrant/AI
Locations (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China