Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- pCR (pathological complete response)
研究概览
简要总结
This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.
Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.
The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.
The total number of patients to be included in this study is 520 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with age between 18 to 70 years old;
- •Histologically confirmed primary invasive breast cancer;
- •Histologically confirmed triple negative breast cancer;
- •Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
- •Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
- •Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- •Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
- •Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
- •Patients had good compliance with the planned treatment, understood the research process and written informed consent.
排除标准
- •Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
- •Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- •Patients with severe systemic infection or other serious diseases;
- •Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
- •Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- •Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
- •Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
- •The researchers considered the patients who were not suitable for enrollment.
研究组 & 干预措施
Nab-paclitaxel + Carboplatin
nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；
干预措施: Nab-paclitaxel + Carboplatin (Drug)
Nab-paclitaxel + Epirubicin
nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles；
干预措施: Nab-paclitaxel + Epirubicin (Drug)
结局指标
主要结局
pCR (pathological complete response)
时间窗: 3 years
No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR
次要结局
- Adverse events (AE)(3 years)
- Objective response rate (ORR)(3 years)
- Disease free survival（DFS）(3 years)
研究者
Cuizhi GENG
M.D.
Hebei Medical University Fourth Hospital