A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
研究概览
简要总结
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
详细描述
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
Patients will be placed into one of 2 arms.
- Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
- Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage II or III breast cancer
- •HER-2 positive tumors
- •Older than 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to
- •ANC > 1,500/mm3
- •Hemoglobin > 9gm/dl
- •Platelets > 100,000mm3
- •Creatinine < 2mg/dl
- •Glucose < 200mg/dl
- •Bilirubin < 1.5 x ULN
排除标准
- •Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
- •Pregnant or breast-feeding women
- •Serious illness, or medical or psychiatric condition
- •Uncontrolled infections
- •Active or severe cardiovascular or pulmonary disease
- •Patients with left ventricular ejection fraction < 50%
- •Peripheral neuropathy of any etiology that exceeds grade 1
- •Prior history of malignancy
- •Uncontrolled diabetes
研究组 & 干预措施
Arm 1
Herceptin/navelbine
干预措施: Herceptin (Drug)
Arm 1
Herceptin/navelbine
干预措施: Navelbine (Drug)
Arm 2
Taxotere/carboplatin/herceptin
干预措施: Herceptin (Drug)
Arm 2
Taxotere/carboplatin/herceptin
干预措施: Taxotere (Drug)
Arm 2
Taxotere/carboplatin/herceptin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
时间窗: 12 weeks
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
次要结局
未报告次要终点
研究者
Eric Winer, MD
Chief Division of Women's Cancers
Dana-Farber Cancer Institute