NCT00191243已完成2 期
A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Time to treatment failure (TTTF)
研究概览
简要总结
Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine.
Aim of the study is to assess the optimal dosage and safety in this setting.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically verified diagnosis of breast carcinoma, at first diagnosis
- •restricted previous adjuvant chemotherapy (completed >6 months prior the study)
- •measurable and/or non-measurable disease
- •previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
- •performance status 0-2 (WHO, Zubrod)
- •adequate bone marrow reserve defined
- •adequate liver / renal functions defined
排除标准
- •any prior systematic chemotherapy for metastatic breast cancer
- •expected survival time less than 12 weeks
- •past or current history of malignant neoplasm other than breast carcinoma
- •except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
- •known brain metastases/leptomeningeal involvement
- •active uncontrolled infection
- •symptomatic peripheral neuropathy > grade 2 according to NCI
- •patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
- •concomitant illness that is contraindication to the use of corticosteroids
- •other concomitant serious illness or medical condition, which may worsen due to the treatment
研究组 & 干预措施
B
Experimental
干预措施: Gemcitabine (Drug)
A
Experimental
干预措施: Gemcitabine (Drug)
A
Experimental
干预措施: docetaxel (Drug)
B
Experimental
干预措施: docetaxel (Drug)
结局指标
主要结局
Time to treatment failure (TTTF)
时间窗: baseline to stopping treatment
次要结局
- Duration of response(time of response to progressive disease)
- Overall survival(baseline to date of death from any cause)
- Time to progressive disease(baseline to measured progressive disease)
- Response rate(baseline to measured progressive disease)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast CancerEarly-Stage Breast CancerNCT00636441Duke University56
已完成
2 期
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast CancerMetastatic Breast CancerNCT00480597Ludwig-Maximilians - University of Munich141
Unknown
2 期
Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast CancerMetastatic Breast CancerNCT02544243Shandong Cancer Hospital and Institute200
尚未招募
2 期
Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast CancerMetastatic Breast CancerNCT04143906Shandong Cancer Hospital and Institute200
已完成
不适用
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast CancerBreast Cancer FemaleHER2-negative Breast CancerNCT06636591Fudan University14