'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 90
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.
详细描述
OBJECTIVES:
- Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine.
- Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients.
- Compare the serious adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2 status (3+ overexpression vs other vs not measured), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.
Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed invasive breast cancer
- •Early stage disease
- •Completely resected disease
- •No more than 8 weeks since prior resection
- •Any nodal status
- •Indication for adjuvant chemotherapy
- •No metastatic disease
- •Hormone receptor status:
- •Estrogen receptor negative or weakly positive OR
- •Estrogen receptor positive AND progesterone receptor negative or weakly positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm3
- •Platelet count greater than 100,000/mm3
- •Hemoglobin greater than 9 g/dL
- •Bilirubin normal
- •AST and ALT no greater than 1.5 times normal
- •Creatinine no greater than 1.5 times normal
- •Fit to receive study chemotherapy
- •No active uncontrolled infection
- •No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix
- •No other concurrent medical or psychiatric problems that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy
- •See Disease Characteristics
排除标准
- 未提供