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Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
Sponsor: Xinhong Wu, PhD
Summary
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
Official title: Single-arm Exploratory Study of Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-12-20
Completion Date
2027-06-20
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
CDK4/6 inhibitors+Endocrine Therapy
CDK4/6 inhibitors:dalpiciclib,palbociclib,abemaciclib,ribociclib
Locations (1)
No. 119 Zhuodaoquan South Road
Wuhan, Hubei, China