Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Best Overall Response
研究概览
简要总结
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with histological or cytological proven diagnosis of breast cancer
- •Stage IV disease
- •Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- •Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
- •Adequate organ function
排除标准
- •Prior chemotherapy for metastatic disease
- •Previous radiation therapy is allowed but must not have included whole pelvis radiation
- •Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- •Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
- •Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than
- •History of significant neurological or mental disorder, including seizures or dementia
研究组 & 干预措施
Gemcitabine + Paclitaxel
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles.
干预措施: gemcitabine (Drug)
Gemcitabine + Paclitaxel
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles.
干预措施: paclitaxel (Drug)
Gemcitabine + Carboplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles.
干预措施: gemcitabine (Drug)
Gemcitabine + Carboplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles.
干预措施: carboplatin (Drug)
Gemcitabine + Cisplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles
干预措施: gemcitabine (Drug)
Gemcitabine + Cisplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles
干预措施: cisplatin (Drug)
结局指标
主要结局
Best Overall Response
时间窗: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
次要结局
- Number of Participants With a Time to Treatment Failure (TTTF) Event(randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months))
- Progression Free Survival (PFS)(baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization))
- Duration of Response(time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization))
- Overall Survival(baseline to date of death from any cause (up to 34 months))