Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical objective and pathological responses to chemotherapy
研究概览
简要总结
The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.
详细描述
Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.
Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Women with locally advanced women breast cancer
- •Histology: ductal ou lobular invasive histology
- •Agreement to take part in the study and signature of the informed consent
- •Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
- •ECOG 0 or I
排除标准
- •Not clinical stage III
- •Inflammatory breast cancer
- •Previous treatment
- •Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
- •Pregnancy
- •Absence of clinical condition to receive chemotherapy
研究组 & 干预措施
Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
干预措施: doxorubicin (Drug)
Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
干预措施: cyclophosphamide (Drug)
Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
干预措施: paclitaxel (Drug)
Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
干预措施: Surgery (Procedure)
结局指标
主要结局
Clinical objective and pathological responses to chemotherapy
时间窗: 8 months
Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery. Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.
次要结局
- Surgery(5 years)
- Clinical, radiologic and pathologic correlation(3 years)
- Overall actuarial survival(5 years)
- Pathologic complete response(9 months)