NCT03907800招募中2 期
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pathological complete response (ypT0/is ypN0) rate
研究概览
简要总结
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- •Age at diagnosis ≥ 18 years, female.
- •Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.
- •cT2-4NanyM0 or cTanyN1-3M0
- •ECOG ≤ 1, LVEF ≥ 55%.
- •Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
- •Patients must be available and compliant for treatment and follow-up.
排除标准
- •Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
- •Known or suspected congestive heart failure (> NYHA I)
- •Currently active infection or severe symptomatic visceral disease.
- •Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
- •rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
- •Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- •Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
研究组 & 干预措施
Nab-paclitaxel + Carboplatin ± Herceptin
Experimental
干预措施: Nab-paclitaxel (Drug)
Nab-paclitaxel + Carboplatin ± Herceptin
Experimental
干预措施: Carboplatin (Drug)
Nab-paclitaxel + Carboplatin ± Herceptin
Experimental
干预措施: Herceptin (Drug)
结局指标
主要结局
Pathological complete response (ypT0/is ypN0) rate
时间窗: 16 weeks (at the time of definitive surgery)
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
次要结局
- Distant disease-free survival (DDFS)(5 years)
- Breast conservation rate(16 weeks (at the time of definitive surgery))
- Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped(during treatment (16 weeks))
- Invasive disease-free survival (IDFS)(5 years)
- Objective response rate (ORR)(16 weeks (at the time of definitive surgery))
研究者
研究点 (1)
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