Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The pathological complete response rate to two consequent induction preoperative chemotherapy regimens
研究概览
简要总结
The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.
详细描述
Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.
One of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age ≥18 years≤75
- •Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
- •Stages Т2-4 N 2-3 M0
- •Signed inform consent
排除标准
- •Previous treatment for this breast cancer
- •History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
- •Pregnancy or breast-feeding
- •Serious concurrent diseases or conditions that may alter chemotherapy conduction
研究组 & 干预措施
2 consequent anthracycline-taxane based chemotherapy regimens
Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
干预措施: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine (Drug)
结局指标
主要结局
The pathological complete response rate to two consequent induction preoperative chemotherapy regimens
时间窗: After 18 weeks of induction chemotherapy
次要结局
- Disease-free survival(3 years)
研究者
Mona Frolova
Senior Research Associate of Department of Clinical Pharmacology and Chemotherapy
Russian Academy of Medical Sciences