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这是一项关于乳腺癌的III 期研究，登记的药物或干预包括Dalpiciclib+AI ± OFS；TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy，当前状态为招募中。登记地点显示中国上海有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Dalpiciclib+AI ± OFS；TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy · III 期
登记条件中文摘要
年龄范围：18岁至70岁
登记的基本范围为女性，年龄18岁至70岁；以下仅摘录8项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出8项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Fudan University Shanghai Cancer Center · 上海
入选条件原文摘录
以下为摘录，请打开原始登记查看完整入排标准。
- 1. Female, aged 18 to 70 years.
- 2. Histologically confirmed early breast cancer with pathological stage T1N0, 0.5 cm \< tumor size ≤ 2 cm, ER-positive/HER2-negative, with ER expression ≥ 50%; and willingness to receive adjuvant dalpiciclib treatment.
- 3. Presence of at least one of the following high-risk features:
- Ki-67 index ≥ 50%; Grade 3 (G3) tumor; an indication for chemotherapy based on results from multigene assays, including the 21-gene recurrence score and the 70-gene signature ; Age ≤ 40 years.
- 4. ECOG performance status: 0 to 1.
- 5. Adequate organ function, defined as meeting the following criteria:
- Hematology (no blood transfusion within 14 days): Hemoglobin (HB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) ≥ 100 × 10⁹/L.
- Biochemistry: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; Serum Creatinine (Cr) ≤ 1 × ULN, with creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula).
联系前需要确认
请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT07432178；登记信息更新于 2026-09-28；本站同步于 2026-10-08，中国中心当前名额未经人工确认。