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Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer

NCT07616453 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-06-01

No results posted yet for this study

Summary

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.

Conditions

  • HR+/HER2- Early Breast Cancer

Interventions

DRUG

Culmerciclib

CDK2/4/6 inhibitor

DRUG

Aromatase Inhibitors

Letrozole or anastrozole

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yiding Chen · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2028-05-05
Completion
2033-05-05

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 NCT07616453 on ClinicalTrials.gov