A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 489
- 试验地点
- 10
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2
详细描述
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
- •HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
- •Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- •Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible)
- •Absence of any clinical or radiological evidence of local or metastatic disease
- •Premenopausal or postmenopausal women aged 18-75 years old
- •Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
- •Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
- •Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
- •Written informed consent
排除标准
- •Positive pregnancy test.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Other concurrent uncontrolled illness.
- •Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
- •Previous history of other invasive malignancy other than non-melanomatous skin cancer.
研究组 & 干预措施
1
FEC -> TXT+H 12m
干预措施: Docetaxel (Drug)
1
FEC -> TXT+H 12m
干预措施: Trastuzumab (Drug)
1
FEC -> TXT+H 12m
干预措施: Epirubicin (Drug)
1
FEC -> TXT+H 12m
干预措施: Cyclophosphamide (Drug)
1
FEC -> TXT+H 12m
干预措施: 5-fluoruracil (Drug)
1
FEC -> TXT+H 12m
干预措施: Granulocyte-colony stimulating growth factor (Drug)
2
FEC -> TXT+H 6m
干预措施: Docetaxel (Drug)
2
FEC -> TXT+H 6m
干预措施: Epirubicin (Drug)
2
FEC -> TXT+H 6m
干预措施: Cyclophosphamide (Drug)
2
FEC -> TXT+H 6m
干预措施: 5-fluoruracil (Drug)
2
FEC -> TXT+H 6m
干预措施: Granulocyte-colony stimulating growth factor (Drug)
2
FEC -> TXT+H 6m
干预措施: Trastuzumab (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: 3 years
次要结局
- Overall survival(5 years)
- Τoxicity profile(Toxicity assessment on each chemotherapy cycle)
- Recurrence rate(Relapses by the time of 3-years follow up)
- Quality of life between the two treatment arms(Assessment every two cycles)