Antitumor Immune Responses in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: a Phase II Study With Trastuzumab and Concomitant Weekly Paclitaxel in Patients With HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel and then if responding further 12 weeks and then with surgical resection, patients with HER2 negative breast carcinoma will be treated with 4 cycles (12 weeks) of epirubicin and taxotere. If responding 4 more cycles (12 weeks). Patients progressing will be treated depending on physician's and patient's preference
详细描述
Primary Objective: to determine the pathological complete response (pCR) and correlation with immune response.
Secondary Objectives:
- to determine the progression free survival (PFS) and overall survival (OS);
- to evaluate the safety of the treatment with particular attention to cardiac safety.
Inclusion Criteria:
- Histologically proven breast carcinoma evaluated for HER 2 status and immune status
- Locally advanced carcinoma (UICC stage II-III)
- Age < 70 years
- measurable lesions
- ECOG Performance Status 0-2
- Life expectancy > 3 months
- Adequate bone marrow and hepatic functions
- Creatinine Clearance > 40 ml/min
- Written informed consent
- Patients must be accessible for treatment and follow up
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven breast carcinoma evaluated for HER 2 status and immune status
- •Locally advanced carcinoma (UICC stage II-III)
- •Age < 70 years
- •measurable lesions
- •ECOG Performance Status 0-2
- •Life expectancy > 3 months
- •Adequate bone marrow and hepatic functions
- •Creatinine Clearance > 40 ml/min
- •Written informed consent
- •Patients must be accessible for treatment and follow up.
排除标准
- •Prior chemotherapy or hormonal treatments
- •Brain metastases.
- •Past or current history of neoplasm other than curatively treated.
- •Concurrent treatment with other experimental drugs.
- •Left Ventricular Ejection Fraction (LVEF) <50 %
- •History of significant neurological or psychiatric disorders.
研究组 & 干预措施
Locally advanced HER2+ breast cancer pts
HER2 positive (defined as 3+ at Herceptest or FISH/CISH positive):
treatment with Trastuzumab 4mg/kg first time, then 2 mg/kg weekly with concomitant paclitaxel 80 mg/mq weekly (one cycle corresponding to 4 weeks) for 12 weeks (3 cycles). Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 6 cycles), then surgical excision
干预措施: Trastuzumab (Drug)
Locally advanced HER2+ breast cancer pts
HER2 positive (defined as 3+ at Herceptest or FISH/CISH positive):
treatment with Trastuzumab 4mg/kg first time, then 2 mg/kg weekly with concomitant paclitaxel 80 mg/mq weekly (one cycle corresponding to 4 weeks) for 12 weeks (3 cycles). Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 6 cycles), then surgical excision
干预措施: Paclitaxel (Drug)
Locally advanced HER2- breast cancer pts
HER2 negative:
treatment with Epirubicin 90 mg/mq and docetaxel 75 mg/mq every 3 weeks for 4 cycles. Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 8 cycles), then surgical excision.
干预措施: Epirubicin (Drug)
Locally advanced HER2- breast cancer pts
HER2 negative:
treatment with Epirubicin 90 mg/mq and docetaxel 75 mg/mq every 3 weeks for 4 cycles. Clinical and instrumental evaluation, in responding patients continue for additional 12 weeks (total 8 cycles), then surgical excision.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: 60 months
pCR was defined as no evidence of microscopic residual invasive cancer, both in breast and ipsilateral axillary lymph nodes, or residual carcinoma in situ in the absence of invasive breast cancer
次要结局
- Overall survival(60 months)
- Progression free survival(60 months)
- Host immune response(60 months)
- Cardiac safety(60 months)