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Culmerciclib in HR+/HER2+ Advanced Breast Cancer

NCT07732491 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-29

No results posted yet for this study

Summary

This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.

Culmerciclib is a novel oral cyclin-dependent kinase 2/4/6 (CDK2/4/6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy.

Patients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up.

The primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.

Conditions

  • Breast Cancer
  • Metastastic Breast Cancer
  • HER2+ Advanced Breast Cancer

Interventions

DRUG

Culmerciclib

Culmerciclib in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2035-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07732491 on ClinicalTrials.gov