A Phase III，Randomized ，Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Disease free survival after adjuvant chemotherapy within five years
研究概览
简要总结
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.
详细描述
Individualized treatment of breast cancer has become one of the main directions in the clinical and research areas of breast cancer,and the individualized treatment of the estrogen receptor(ER) positive patients which covered 65% of total cases is of vital importance. Historical research showed that among the ER-positive and HER2-negative breast cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from chemotherapy,compared with the Luminal A breast cancer with Ki67<14%. And the results of our previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence whether switching to Anthracycline-based post operative protocol can benefit them.So that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2 negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and OS of two subgroup.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Chinese population surgery patients with invasive breast cancer；
- •Stage II-III；
- •ER positive；
- •HER2 negative；
- •Ki67≥14%；
- •Aged between 18 and 70 years old；
- •The maximum diameter of the primary tumor greater than 1cm；
- •ECOG score 0-1 points； -Have adequate baseline bone marrow and organ function reserve : absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3 hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular ejection fraction ( LVEF ) ≥ 50%
排除标准
- •Non - Chinese population of patients；
- •Non- invasive cancer patients;
- •Inflammatory Breast Cancer patients;
- •Metastatic breast cancer patients;
- •HER2 positive patients;
- •Ki67<14% patients;
- •No adequateBaseline bone marrow or organ function reserve;
- •ECOG PS score ≥ 2 points;
- •Younger than 18 years of age or greater than 70 years old;
- •Already accepted therapy including chemotherapy , endocrine therapy or targeted therapy before neoadjuvant treatment;
- •HER2-positive patients with left ventricular ejection fraction less than 55 % can not receiving Herceptin;
- •Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .
结局指标
主要结局
Disease free survival after adjuvant chemotherapy within five years
时间窗: Within 5 years after adjuvant chemotherapy
Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
Overall survival after adjuvant chemotherapy within five years
时间窗: Within five years after adjuvant chemotherapy
Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.
次要结局
- Imaging evaluation after neoadjuvant chemotherapy(within the 21 days after neoadjuvant chemotherapy)
研究者
Liao Ning
MD,PhD
Guangdong Academy of Medical Sciences