NCT00638963终止2 期
Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Percent of Participants With Recurrence of Brain Metastases
研究概览
简要总结
The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.
详细描述
Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic breast cancer.
- •Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
- •No clinical sign of brain progression.
- •At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Life expectancy ≥3 months.
- •Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
- •Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
- •AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
- •Serum creatine <1.5 x ULN.
- •Effective contraception if the risk of conception exists.
排除标准
- •Concurrent chronic systemic immune therapy not indicated in the study protocol.
- •Any investigational agent(s) within 4 weeks prior to entry.
- •Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
- •Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
- •Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
- •Known drug abuse/alcohol abuse.
- •Legal incapacity or limited legal capacity.
- •Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
- •Women who are pregnant or breastfeeding.
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
研究组 & 干预措施
Temozolomide
Experimental
干预措施: temozolomide (Drug)
结局指标
主要结局
Percent of Participants With Recurrence of Brain Metastases
时间窗: 1 Year
The analysis could not be performed due to low enrollment.
次要结局
- Number of Days With Progression-free Survival (PFS)(24, 38, and 52 weeks)
- Number of Days With Disease-free Survival (DFS)(24, 38, and 52 weeks)
- Number of Days With Distant Disease-free Survival (DDFS)(24, 38, and 52 weeks)
- Number of Days With Brain Recurrence-free Survival (BRFS)(24,38, and 52 weeks)
- Number of Days on Temozolomide Treatment(Baseline to 24 Weeks)
- Number of Participants Who Had at Least One Dose Reduction During Treatment(Baseline to 24 Weeks)
- Total Dose of Temozolomide Taken(Baseline to 24 Weeks)
- Number of Participants Who Had at Least One Treatment Omission During Treatment(Baseline to 24 Weeks)
- Number of Participants Who Completed the Third Cycle of Treatment(Baseline to 24 Weeks)
研究者
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