OncoMatch/Clinical Trials/NCT07732491
Culmerciclib in HR+/HER2+ Advanced Breast Cancer
Is NCT07732491 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Culmerciclib for breast cancer.
Treatment: Culmerciclib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≥10%)
Hormone receptor positivity is defined as estrogen receptor (ER) expression of at least 10%
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with HER2 gene amplification by FISH)
HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by fluorescence in situ hybridization (FISH)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic anti-tumor therapy — first-line for locally recurrent or metastatic disease
Patients must have achieved a response to first-line systemic anti-tumor therapy for locally recurrent or metastatic disease, with at least 4 cycles of chemotherapy completed and no evidence of radiographic progression.
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥85 g/L (without transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening)
Kidney function
BUN and creatinine ≤1×ULN or calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
TBIL <1.5×ULN; ALT and AST <2.5×ULN (or <5×ULN with liver metastases)
Adequate major organ function as defined by the following criteria: Hematologic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥85 g/L (without transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening). Biochemical function: total bilirubin (TBIL) <1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5×ULN (or <5×ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine ≤1×ULN or calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07732491 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic anti-tumor therapy.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify