Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,803
- 试验地点
- 72
- 主要终点
- Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
研究概览
简要总结
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.
详细描述
The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors.
A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate).
Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).
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
- 19 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal, hormone receptor-positive patient
- •Histologically verified (minimally) invasive breast cancer, local radical treatment
- •0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes)
- •Tumor stage: pT1b-3, yT0 or yT1a
排除标准
- •T1a, T4d, yT4; M1
- •Previous breast tumor irradiation
- •Previous or concurrent chemotherapy (except for preoperative chemotherapy)
- •Serum creatinine > 1.5 x UNL or creatinine clearance < 60 ml/min
研究组 & 干预措施
TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
干预措施: goserelin (Other)
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
干预措施: anastrozole (Drug)
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
干预措施: zoledronic acid (Drug)
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
干预措施: goserelin (Other)
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
干预措施: tamoxifen (Drug)
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
干预措施: zoledronic acid (Drug)
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
干预措施: goserelin (Other)
AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
干预措施: anastrozole (Drug)
AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
干预措施: goserelin (Other)
TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
干预措施: tamoxifen (Drug)
结局指标
主要结局
Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
时间窗: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
时间窗: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
次要结局
- Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)(Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
- Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)(Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
- Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)(Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
- Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)(Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)