OncoMatch/Clinical Trials/NCT06107673
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
Is NCT06107673 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Dalpiciclib · Aromatase inhibitor · Docetaxel · Epirubicin Hydrochloride · Cyclophosphamide — This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 strong positive for ER (≥50% tumor cells positive by IHC) (≥50% tumor cells positive by IHC)
Strong positive for ER: ER immunohistochemistry test shows 50% or more tumor cells positive.
Required: HER2 (ERBB2) negative (IHC (-, +) or (++) and ISH negative)
negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative.
Disease stage
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: excluding diagnostic biopsy for primary breast cancer
Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer)
Cannot have received: endocrine therapy
Exception: excluding diagnostic biopsy for primary breast cancer
Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer)
Cannot have received: anti-HER2 biologic therapy
Exception: excluding diagnostic biopsy for primary breast cancer
Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer)
Lab requirements
Blood counts
NEUT# ≥ 1.5×10^9 /L; WBC ≥ 3.0×10^9 /L; Platelets ≥ 90×10^9 /L; Hemoglobin ≥ 90 g/L
Kidney function
Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5× ULN; ALT/AST ≤ 2× ULN
Cardiac function
baseline LVEF ≥ 50%, no significant cardiac diseases (≤ NYHA class I)
routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10^9 /L; White blood cell count (WBC) ≥ 3.0×10^9 /L; Platelets ≥ 90×10^9 /L; Hemoglobin ≥ 90 g/L. liver and kidney function tests are essentially normal: Total bilirubin (TBIL) ≤ 1.5× ULN; ALT/AST ≤ 2× ULN; Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min. baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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