A Pilot Study of Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pathologic complete response
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.
详细描述
Dose-dense regimens have been shown to improve outcome when given as adjuvant therapy to patients with breast cancer compared with their three weekly counterparts. It is unknown if dose dense neoadjuvant therapy will improve survival in resectable breast cancer. This study is to evaluate the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early 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
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed invasive breast carcinoma
- •Clinical stage Ⅱ-ⅢB
- •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
carboplatin and paclitaxel ± trastuzumab
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer.
干预措施: carboplatin and paclitaxel and or without trastuzumab (Drug)
结局指标
主要结局
pathologic complete response
时间窗: one year
次要结局
未报告次要终点