NCT00944424Unknown3 期
GORG - 002 Randomized Phase III Trial to Determine the Effectiveness of High Dose Versus Standard Dose of Vitamin D2 (Ergocalciferol) Given With Docetaxel in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 6
- 主要终点
- Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date.
研究概览
简要总结
Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer
详细描述
2 Arms Randomization in patients with metastatic breast cancer.
Arm A = Docetaxel + High dose Vitamin D2
Arm B = Docetaxel + Standard dose Vitamin D2
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
- Single (Investigator)
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
- •Histologically proven metastatic adenocarcinoma of the breast.
- •Gender: female.
- •Age ≥18 years.
- •ECOG performance status ≤ 2.(see appendix I)
- •25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
- •No more than 1 prior chemotherapy regimen not including Docetaxel or Paclitaxel for metastatic breast cancer.
- •Patients progressed on Doxorubicin or epirubicin as first line for metastatic breast cancer is eligible.
- •Concurrent bisphosphonate therapy allowed.
- •Life expectancy more than 6 months
- •At least 12 months since prior adjuvant or neo-adjuvant chemotherapy including Taxanes regimens.
- •Adequate hematologic, hepatic and renal function.
- •Written informed consent.
排除标准
- •Pregnant or lactating women.
- •Male breast cancer.
- •Women of childbearing potential unless surgically sterile or using adequate measures of contraception.
- •Metastatic inflammatory breast cancer.
- •CNS metastasis.
- •Leptomeningeal carcinomatosis.
- •Malignant hypercalcemia.
- •History of kidney stones.
- •History of active primary hyperparathyroidism.
- •Normal 25 (OH) Vitamin D level ≥100 nmol/L or ≥ 40 ng/L.
- •Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer.
- •Patient on any anti-Psychotic medications or Steroid therapy.
- •History of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue).
- •Any of the following abnormal baseline hematological values:
- •ANC < 1.0 x109/L, or platelets < 100.000 x 109/L.
- •Any of the following abnormal laboratory tests: total serum bilirubin >2.00 x ULN (upper limit of normal), AST, ALT > 2.5 x ULN or ALP >2.50 x ULN (upper limit of normal).
研究组 & 干预措施
Arm A
Experimental
Arm A = Docetaxel + High dose Vitamin D2
干预措施: Docetaxel + High dose Vitamin D2 (Drug)
Arm B
Active Comparator
Docetaxel + Standard dose Vitamin D2
干预措施: Docetaxel + Standard dose Vitamin D2 (Drug)
结局指标
主要结局
Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date.
时间窗: 1 year
次要结局
- Overall survival is defined as the time from start of Docetaxel to death due to any cause. Patients for whom no death is captured on the clinical database are censored at the last date they were known to be alive.(1 year)
研究者
研究点 (6)
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