Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 4
- 主要终点
- Time to Disease Progression (Initial Treatment)
研究概览
简要总结
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
- •Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
- •Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
- •Patients must have either measurable or non-measurable (evaluable) disease
- •Prior radiation therapy allowed of less than 25% of the bone marrow
排除标准
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- •Parenchymal or leptomeningeal brain metastases
- •Peripheral neuropathy greater than or equal to grade 2
- •Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
- •Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
- •Concomitant Herceptin is not allowed
研究组 & 干预措施
Gemcitabine + Docetaxel
干预措施: gemcitabine (Drug)
Gemcitabine + Docetaxel
干预措施: docetaxel (Drug)
Capecitabine + Docetaxel
干预措施: docetaxel (Drug)
Capecitabine + Docetaxel
干预措施: capecitabine (Drug)
结局指标
主要结局
Time to Disease Progression (Initial Treatment)
时间窗: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
次要结局
- Time to Disease Progression (Crossover Treatment)(Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months))
- Progression-Free Survival (Initial Treatment)(Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months))
- Progression-Free Survival (Crossover Treatment)(First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months))
- Duration of Response (Initial Treatment)(Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months))
- Duration of Response (Crossover Treatment)(Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months))
- Overall Survival(Date of randomization to date of death from any cause (up to 82 months))
- Best Overall Response (Initial Treatment)(Best response from start of treatment until disease progression/recurrence (up to 82 months))
- Best Overall Response (Crossover Treatment)(Best response from start of treatment until disease progression/recurrence (up to 82 months))
- Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)(Baseline until crossover treatment began (up to 82 months))
- Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)(First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths))
- Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)(Baseline until crossover treatment began (up to 82 months))
- Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)(First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months))