A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Time to Progressive Disease (TTPD) by Treatment Schedule
研究概览
简要总结
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Histologic diagnosis of metastatic breast cancer (MBC).
- •Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
- •Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
- •Patients with measurable disease.
- •Previous hormonal therapy for adjuvant setting or metastatic disease.
排除标准
- •Previous chemotherapy for MBC
- •Previous chemotherapy with gemcitabine in any setting of disease
- •Patient candidable to treatment with trastuzumab.
研究组 & 干预措施
A: Docetaxel and Gemcitabine (Tri-weekly)
Docetaxel and Gemcitabine (Tri-weekly)
干预措施: Gemcitabine (Drug)
A: Docetaxel and Gemcitabine (Tri-weekly)
Docetaxel and Gemcitabine (Tri-weekly)
干预措施: Docetaxel (Drug)
B: Paclitaxel and Gemcitabine (Tri-weekly)
Paclitaxel and Gemcitabine (Tri-weekly)
干预措施: Gemcitabine (Drug)
B: Paclitaxel and Gemcitabine (Tri-weekly)
Paclitaxel and Gemcitabine (Tri-weekly)
干预措施: Paclitaxel (Drug)
C: Docetaxel and Gemcitabine (Weekly)
Docetaxel and Gemcitabine (Weekly)
干预措施: Gemcitabine (Drug)
C: Docetaxel and Gemcitabine (Weekly)
Docetaxel and Gemcitabine (Weekly)
干预措施: Docetaxel (Drug)
D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel and Gemcitabine (Weekly)
干预措施: Gemcitabine (Drug)
D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel and Gemcitabine (Weekly)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Time to Progressive Disease (TTPD) by Treatment Schedule
时间窗: Baseline up to 49.84 months
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Time to Progressive Disease (TTPD) by Treatment Drug
时间窗: Baseline up to 49.84 months
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
次要结局
- Overall Survival (OS) by Treatment Schedule(Baseline up to 51.64 months)
- Overall Survival (OS) by Treatment Drug(Baseline up to 51.64 months)
- Overall Response Rate (ORR) by Treatment Schedule(Baseline up to 49.84 months)
- Overall Response Rate(ORR) by Treatment Drug(Baseline up to 49.84 months)
- Number of Participants With Serious and Nonserious Adverse Events (AEs)(Baseline up to 51.64 months)
- Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle(Baseline up to 51.64 months)
- Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit(Baseline up to 51.64 months)