A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carboplatin Plus Trastuzumab and Pertuzumab (TCbHP) in the Adjuvant Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,406
- 试验地点
- 1
- 主要终点
- iDFS
研究概览
简要总结
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
详细描述
The objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.
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
- •Women aged 18-70；
- •0-1 for ECOG；
- •Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
- •No gross or microscopic tumor remains after surgical resection；
- •Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
- •Postoperative pathological stage pT1-4N1-3M0；
- •Did not receive neoadjuvant chemotherapy in the past；
- •The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
- •No peripheral neuropathy；
- •Good postoperative recovery, at least 1 week interval between operation；
- •The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
- •Contraception during treatment for women of reproductive age；
- •Cardiac function: LVEF>50% for ultrasound examination；
- •The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。
排除标准
- •Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
- •Have received chemotherapy for advanced disease；
- •Transfer of any part；
- •If any tumor >T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
- •Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
- •Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
- •Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
- •The patient has been enrolled in other clinical trials；
- •Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
- •LVEF<50% (cardiac ultrasound)；
- •Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
- •Known allergy to related drugs；
- •Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
- •Pregnant and lactating women；
- •Those who tested positive for pregnancy before taking the drug after joining the trial；
- •Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
- •Persons without personal freedom and independent capacity for civil conduct。
研究组 & 干预措施
Arm A：TCbHP
Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Docetaxel (Drug)
Arm A：TCbHP
Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: carboplatin (Drug)
Arm A：TCbHP
Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Trastuzumab (Drug)
Arm A：TCbHP
Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Pertuzumab (Drug)
Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Docetaxel (Drug)
Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Trastuzumab (Drug)
Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Pertuzumab (Drug)
Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: Epirubicin (Drug)
Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
iDFS
时间窗: 5 years
invasive Disease Free Survival
次要结局
- DRFS(5 years)
- OS(5 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](through study completion, an average of 1 year)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University