Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer.
详细描述
OBJECTIVES: I. Compare overall survival and local and systemic disease-free survival produced by adjuvant chemoendocrine therapy with 4 courses of anthracycline/cyclophosphamide and concurrent vs. sequential tamoxifen (TMX) or toremifene (TOR) in peri- and postmenopausal women with node-positive breast cancer who are considered suitable for endocrine therapy alone. II. Evaluate these same endpoints in patients randomized to chemoendocrine therapy vs. endocrine therapy alone. III. Evaluate these same endpoints in patients randomized to TMX vs. TOR as the endocrine therapy agent. IV. Compare the quality of life of patients treated on these regimens. V. Compare the toxic effects of these regimens.
OUTLINE: This is a randomized study. Patients are stratified by type of primary therapy and participating institution. Therapy must begin within 6 weeks of surgery. Patients in the first group receive doxorubicin (or epirubicin) and cyclophosphamide every 28 days for a total of 4 cycles and oral tamoxifen daily for 5 years, beginning day 1 of chemotherapy. Patients in the second group receive the same chemotherapy with oral tamoxifen initiated on day 8 of the fourth chemotherapy cycle and continued for 5 years. Patients in the third group receive oral tamoxifen daily for 5 years. Patients in the fourth group are treated the same as the first group, only tamoxifen is replaced by toremifene. Patients in the fifth group are treated the same as the second group, only tamoxifen is replaced by toremifene. Patients in the sixth group receive oral toremifene daily for 5 years. The timing of optional radiotherapy for patients with less than total mastectomy in each group is based on institutional policy; radiotherapy is administered for 5-6 weeks to the remaining breast tissue, chest wall, and lung. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and yearly thereafter.
PROJECTED ACCRUAL: 1,140 patients will be accrued over approximately 9 years, with 1 additional year of follow-up.
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
- — 至 70 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
AC with concurrent tamoxifen
AC for 4 cycles with concurrent tamoxifen for 5 years
干预措施: cyclophosphamide (Drug)
AC with concurrent tamoxifen
AC for 4 cycles with concurrent tamoxifen for 5 years
干预措施: doxorubicin hydrochloride (Drug)
AC with concurrent tamoxifen
AC for 4 cycles with concurrent tamoxifen for 5 years
干预措施: epirubicin hydrochloride (Drug)
AC with concurrent tamoxifen
AC for 4 cycles with concurrent tamoxifen for 5 years
干预措施: tamoxifen citrate (Drug)
AC followed by tamoxifen
AC for 4 cycles followed by tamoxifen to 5 years from randomization.
干预措施: cyclophosphamide (Drug)
AC followed by tamoxifen
AC for 4 cycles followed by tamoxifen to 5 years from randomization.
干预措施: doxorubicin hydrochloride (Drug)
AC followed by tamoxifen
AC for 4 cycles followed by tamoxifen to 5 years from randomization.
干预措施: epirubicin hydrochloride (Drug)
AC followed by tamoxifen
AC for 4 cycles followed by tamoxifen to 5 years from randomization.
干预措施: tamoxifen citrate (Drug)
Tamoxifen alone
Tamoxifen alone for 5 years.
干预措施: tamoxifen citrate (Drug)
AC with concurrent toremifene
AC for 4 cycles with concurrent toremifene for 5 years.
干预措施: cyclophosphamide (Drug)
AC with concurrent toremifene
AC for 4 cycles with concurrent toremifene for 5 years.
干预措施: doxorubicin hydrochloride (Drug)
AC with concurrent toremifene
AC for 4 cycles with concurrent toremifene for 5 years.
干预措施: epirubicin hydrochloride (Drug)
AC with concurrent toremifene
AC for 4 cycles with concurrent toremifene for 5 years.
干预措施: toremifene (Drug)
AC followed by toremifene
AC for 4 cycles followed by toremifene to 5 years from randomization.
干预措施: cyclophosphamide (Drug)
AC followed by toremifene
AC for 4 cycles followed by toremifene to 5 years from randomization.
干预措施: doxorubicin hydrochloride (Drug)
AC followed by toremifene
AC for 4 cycles followed by toremifene to 5 years from randomization.
干预措施: epirubicin hydrochloride (Drug)
AC followed by toremifene
AC for 4 cycles followed by toremifene to 5 years from randomization.
干预措施: toremifene (Drug)
Toremifene alone
Toremifene alone for 5 years.
干预措施: toremifene (Drug)
结局指标
主要结局
Overall survival
时间窗: 17 years after randomization
Time from randomization to death.
次要结局
- Disease-free and systemic disease-free survival.(17 years from randomization)
- Quality of life(17 years from randomization)
- Toxicity(17 years after randomization)