Randomized Trial of High-dose Epirubicin and Cyclophosphamide x 3 Supported by Peripheral Blood Progenitor Cells Versus Anthracycline and Cyclophosphamide x 4 Followed by Cyclophosphamide, Methotrexate, and 5-fluorouracil x 3 as Adjuvant Treatment for High Risk Operable Stage ii and Stage Iii Breast Cancer in Premenopausal and Young Postmenopausal (Less Than or Equal to 65 Yrs) Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 11
- 主要终点
- Disease-free survival.
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if high-dose combination chemotherapy plus peripheral stem cell transplantation is more effective than standard combination chemotherapy for breast cancer.
PURPOSE: Randomized phase III trial to compare high-dose combination chemotherapy plus peripheral stem cell transplantation with standard combination chemotherapy in treating women with stage II or stage III breast cancer.
详细描述
OBJECTIVES: I. Compare the survival, disease-free survival, and systemic disease-free survival of women with high-risk, operable stage II/III breast cancer treated with three courses of dose-intensive epirubicin/cyclophosphamide (EC) supported by granulocyte colony-stimulating factor (G-CSF) and G-CSF-mobilized peripheral blood stem cells vs. standard EC followed by cyclophosphamide/methotrexate/fluorouracil. II. Compare the toxicity, duration of quality-adjusted time without symptoms and toxicity, and quality of life associated with these two treatments. III. Evaluate the cost effectiveness of these two treatments.
OUTLINE: This is a randomized study. Patients are stratified by estrogen receptor status and menopausal status. Within 6 weeks of surgery, patients in the first group receive epirubicin (preferred) or doxorubicin plus cyclophosphamide every 3 weeks for 4 courses followed by conventional cyclophosphamide, methotrexate, and fluorouracil (CMF) every 4 weeks for 3 courses. Patients in the second group undergo stem cell mobilization and harvest with granulocyte colony-stimulating factor (G-CSF) followed within 10 weeks of surgery by high-dose chemotherapy with epirubicin and cyclophosphamide followed by peripheral blood stem cell rescue and G-CSF. All patients receive adjuvant tamoxifen, and patients who underwent lumpectomy prior to entry are required to receive adjuvant radiotherapy (radiotherapy is optional for patients who underwent mastectomy prior to entry). Patients are followed every 3 months for 2 years, then q 6 months for 3 years, then yearly.
PROJECTED ACCRUAL: 210 patients will be accrued over 4 years to provide 195 evaluable patients.
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
- 16 Years 至 65 Years（Child, 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
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: CMF regimen (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: cyclophosphamide (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: doxorubicin hydrochloride (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: epirubicin hydrochloride (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: fluorouracil (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: methotrexate (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: tamoxifen citrate (Drug)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: low-LET electron therapy (Radiation)
Standard chemotherapy
EC/AC x 4 followed by CMF x 3 and tamoxifen to 5 years after randomization.
干预措施: low-LET photon therapy (Radiation)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: filgrastim (Biological)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: cyclophosphamide (Drug)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: mesna (Drug)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: tamoxifen citrate (Drug)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: peripheral blood stem cell transplantation (Procedure)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: low-LET electron therapy (Radiation)
Dose-intensive EC
High-dose EC x 3 supported by peripheral blood progenitor cells and tamoxifen to 5 years after randomization.
干预措施: low-LET photon therapy (Radiation)
结局指标
主要结局
Disease-free survival.
时间窗: 16 years after randomization.
Time from randomization to recurrence (including recurrence isolated to the breast), metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
次要结局
- Quality of life.(16 years after randomization.)
- Overall survival.(16 years after randomization.)
- Toxicity.(5 years after randomization.)