Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.
详细描述
Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).
After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).
Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).
After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.
At the time of surgery, re-assessment of the tumor will be done.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have Stage II or III histologically diagnosed breast cancer
- •Primary invasive breast cancers that overexpress the HER2/neu oncogene
- •Age older than 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of < 1
- •White blood cell (WBC) > 4000/mm3
- •Platelet count > 100,000/mm3
- •Bilirubin < 1 x upper limit of normal (ULN)
- •SGOT < 1 x ULN
- •Creatinine < 1.5mg/dl
- •Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy
排除标准
- •Excisional biopsy, sentinel node dissection or axillary node dissection.
- •Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
- •Pregnant or breast-feeding women
- •Uncontrolled infection
- •Active or severe cardiovascular or pulmonary disease
- •Peripheral neuropathy of any etiology that exceeds grade 1
- •Prior history of malignancy treated without curative intent
- •Uncontrolled diabetes
结局指标
主要结局
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
次要结局
- To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy(3 years)
研究者
Harold J. Burstein, MD, PhD
Associate Professor of Medicine
Dana-Farber Cancer Institute