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RECRUITING
NCT07666555
PHASE2

A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have progressed after first-line endocrine therapy

Official title: A Phase II Clinical Trial Evaluating the Efficacy and Safety of Culmerciclib Combined With Fulvestrant Compared to an Investigator-Selected CDK4/6 Inhibitor Combined With Fulvestrant in Patients With HR-Positive, HER2-Negative Breast Cancer Who Have Progressed After First-Line Endocrine Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-06-06

Completion Date

2029-12-30

Last Updated

2026-06-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

CDK4/6 inhibitor

investigator's choice of CDK4/6 inhibitor

DRUG

Culmerciclib

CDK2/4/6 inhibitor

DRUG

Fulvestrant

Fulvestrant

Locations (1)

Fudan Cancer Center

Shanghai, China