Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- complete pathologic response rate
研究概览
简要总结
The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive breast cancer.
详细描述
Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery, has been shown to reduce tumor size and permit better resection of HER-2 positive breast cancers. This study will evaluate the activity of a neoadjuvant treatment with docetaxel and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx, cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. Patients will undergo breast cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. Adjuvant therapy after surgery will be given according to existing guidelines, and will include an additional 10 cycles of trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast cancer
- •Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC classification, 2002)
- •Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)
- •Age> 18 e < 65 years
- •Left ventricular ejection fraction (LVEF) > or = 55%
- •ECOG Performance Status 0-2
- •Neutrophils > or = 2000/mm³, platelets > or = 100.000/mm³ , hemoglobin > or = 10 g/dl), GOT, GPT and bilirubin < 1.25 x the upper normal limit, creatinine < 1.25 x the upper normal limit.
- •Life expectancy > 3 months
- •Signed informed consent.
排除标准
- •Any prior treatment for breast cancer
- •Metastatic disease (M1)
- •Performance status (ECOG) > or = 3
- •Current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix)
- •Neutrophils < 2.000/mm³ , platelets < 100.000/mm³ , hemoglobin < 10 g/dl.
- •Creatinine > 1.25 x the upper normal limit
- •GOT and/or GPT and/or bilirubin >1.25 x the upper normal limit.
- •Concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol.
- •Congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias
- •Active infection
- •Incapacity or refusal to provide informed consent.
- •Inability to comply with follow up
- •Pregnant or nursing females.
结局指标
主要结局
complete pathologic response rate
次要结局
- toxicity of neoadjuvant treatment
- predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment