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ACTIVE NOT RECRUITING
NCT07130643
PHASE2

Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer

Sponsor: Xinhong Wu, PhD

View on ClinicalTrials.gov

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

Interventions

DRUG

CDK4/6 inhibitors+Endocrine Therapy

CDK4/6 inhibitors:dalpiciclib,palbociclib,abemaciclib,ribociclib

Locations (1)

No. 119 Zhuodaoquan South Road

Wuhan, Hubei, China