TCHP (Docetaxel/Carboplatin/Trastuzumab/Pertuzumab) Versus EC -THP(Epirubicin/ Cyclophosphamide Followed by Docetaxe/Trastuzumab/Pertuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
详细描述
Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
- •Clinical stage #-#B
- •Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- •Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
- •Signed informed consent
- •Adequate organ function within 2 weeks of study entry:
- •Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
- •Patients must be over 18 years old.
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
排除标准
- •• Metastatic disease
- •Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
- •History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
研究组 & 干预措施
Arm A: TCHP
docetaxel/carboplatin/trastuzumab/Pertuzumab
干预措施: TCHP (Drug)
Arm B: EC-THP
epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab
干预措施: TCHP (Drug)
结局指标
主要结局
pCR
时间窗: one year
pathologic complete response
次要结局
未报告次要终点
研究者
KunWang
Professor
Guangdong Provincial People's Hospital