Culmerciclib in HR+/HER2+ Advanced Breast Cancer

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 p

Trial Details

NCT ID
NCT07732491
Phase
PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Culmerciclib
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
  • Hormone receptor-positive and HER2-positive disease. HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplifica…
  • Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing.
  • Patients with brain metastases are eligible if they have asymptomatic central nervous system (CNS) metastases, defined as no CNS symptoms or sympto…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Positive Breast Cancer Trials on Trialify →