A Phase III Randomized Trial With NEOadjuvant Chemotherapy (TAC) With or Without ZOledronic Acid for Patients With HER2- Negative Large Resectable or Locally Advanced Breast Cancer(NEO-ZOTAC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective when given together with zoledronic acid in treating patients with breast cancer.
PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride together with cyclophosphamide and docetaxel to see how well it works with or without zoledronic acid in treating patients with large resectable or locally advanced breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the value of neoadjuvant chemotherapy comprising doxorubicin hydrochloride, cyclophosphamide, and docetaxel with or without zoledronic acid in patients with HER2-negative large resectable or locally advanced breast cancer.
Secondary
- To correlate clinical response with pathological responses in both treatment arms.
- To evaluate the disease-free survival and overall survival of patients treated with this regimen.
- To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant chemotherapy.
- To evaluate heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
干预措施: cyclophosphamide (Drug)
TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
干预措施: docetaxel (Drug)
TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
干预措施: doxorubicin hydrochloride (Drug)
TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
干预措施: zoledronic acid (Drug)
TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
干预措施: neoadjuvant therapy (Procedure)
TAC
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC)
干预措施: cyclophosphamide (Drug)
TAC
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC)
干预措施: docetaxel (Drug)
TAC
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC)
干预措施: doxorubicin hydrochloride (Drug)
TAC
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC)
干预措施: neoadjuvant therapy (Procedure)
结局指标
主要结局
Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic
时间窗: after surgery
次要结局
- Safety and tolerability(during treatment)
- Disease-free survival(3 and 5 years)
- Heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen(at surgery)
- Overall survival(3 and 5 years)
- Correlation of clinical response with pathological responses of both treatment arms(after surgery)