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

NCT07796880 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • HR-Positive, HER2-Negative Early-Stage Breast Cancer

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Chang Gong · Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2028-09-15
Completion
2033-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796880 on ClinicalTrials.gov