Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 786
- 试验地点
- 27
- 主要终点
- Disease-free survival
研究概览
简要总结
To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.
详细描述
This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.
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
- 未提供
排除标准
- •Prior systemic of breast cancer, including chemotherapy;
- •Metastatic breast cancer;
- •With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
- •Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
- •Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
- •Contraindication for using dexamethasone;
- •History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP>180 mmHg or diastolic BP>100 mmHg);
- •Has peripheral neuropathy no less than grade 1;
- •Patient is pregnant or breast feeding;
- •Patients with psychiatric disorder or other diseases leading to incompliance to the therapy;
- •Known severe hypersensitivity to any drugs in this study;
- •Treatment with any investigational drugs within 30 days before the beginning of study treatment.
研究组 & 干预措施
Taxanes
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
干预措施: Epirubicin plus Cyclophosphamide (Drug)
Taxanes
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
干预措施: Taxanes (Drug)
Taxanes plus carboplatin
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
干预措施: Epirubicin plus Cyclophosphamide (Drug)
Taxanes plus carboplatin
Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
干预措施: Taxanes plus Carboplatin (Drug)
结局指标
主要结局
Disease-free survival
时间窗: From time of randomization to 5 years after enrollment.
The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first.
次要结局
- Distant disease-free survival(From time of randomization to 5 years after enrollment.)
- Overall Survival(From time of randomization to 5 years after enrollment.)
- Incidence of adverse events(From randomization to four weeks after end of study treatment)
研究者
Kunwei Shen
professor
Shanghai Jiao Tong University School of Medicine