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NOT YET RECRUITING
NCT07796880
PHASE2

Neoadjuvant Culmerciclib Combined With Endocrine Therapy for HR-Positive HER2-Negative Breast Cancer

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients with HR-positive, HER2-negative early-stage breast cancer.

Official title: Neoadjuvant Culmerciclib Combined With Endocrine Therapy Versus Endocrine Therapy Alone for HR-Positive, HER2-Negative Breast Cancer: a Single-Center, Open-Label, Randomized-Controlled Phase II Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-09-15

Completion Date

2033-03-15

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

Culmerciclib

24 weeks of continuous oral Culmerciclib 180 mg once daily ,continuously

DRUG

Aromatase Inhibitor (AI)

Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg, administered orally once daily continuously

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China