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

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 appro

Trial Details

NCT ID
NCT07616453
Phase
PHASE2
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Culmerciclib
  • Aromatase Inhibitors
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Ki-67 ≥20% assessed on core needle biopsy samples. Newly diagnosed, treatment-naïve patients with stage I-IIIA disease according to the AJCC 8th ed…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate bone marrow function:
  • Absolute neutrophil count ≥1.5 × 10⁹/L (without growth factor support within 14 days);

For full eligibility, visit ClinicalTrials.gov.

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