NCT03315364进行中（未招募）2 期
A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 549
- 试验地点
- 51
- 主要终点
- [Phase II] Objective Response Rate (ORR)
研究概览
简要总结
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key inclusion/
排除标准
- •Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer.
- •Measurable disease (revised RECIST, version 1.1).
- •Hormone receptor (ER/PR) positive or negative, HER2 negative.
- •Subjects were eligible for the study regardless of their previous lines of endocrine therapy.
- •No prior chemotherapy is allowed in metastatic disease.
- •Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day.
- •ECOG performance status ≤
- •Neuropathy grade <
- •Subjects with central nervous system metastasis should be excluded.
研究组 & 干预措施
Liporaxel® (oral paclitaxel)
Experimental
- 28 days (4 weeks) will be set as one cycle of administration and Liporaxel® will be administered for 3 weeks, twice a day, every morning and evening (D1, D8, D15) and will take a week off on 4th week.
- Liproaxel® 200mg/m2 will be orally administered twice a day (morning, evening) 1 hour after meal for D1, D8, D15 of every cycle. 10 hour-interval is recommended for between each administration.
干预措施: Oral paclitaxel (Drug)
Taxol® (IV paclitaxel)
Active Comparator
- 28 days (4 weeks) will be set as one cycle and for every 3 week administration, 1 week off dose period will be given.
- Taxol® 80mg/m2 will be administered via IV and it must be diluted before drip administration. Dilute with 0.9% sodium chloride injection solution to make final concentration of 0.3-1.2 mg/mL.
干预措施: Paclitaxel injection (Drug)
结局指标
主要结局
[Phase II] Objective Response Rate (ORR)
时间窗: Participants will be followed every 6 weeks until progression, an expected average of 9 months.
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
[Phase III] Progression Free Survival (PFS)
时间窗: From date of randomization, assessed up to 18 months.
Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death
次要结局
- [Phase II] Progression Free Survival (PFS)(From date of randomization, assessed up to 18 months.)
- [Phase III] Objective Response Rate (ORR)(Participants will be followed every 6 weeks until progression, an expected average of 9 months.)
- [Phase II&III] Overall Survival(OS)(Until 6 months after the last participant is enrolled, assessed minimum to 18 months.)
- [Phase II&III] Time to Treatment Failure(TTF)(through study completion, an expected average of 4.5 year.)
- [Phase II&III] Disease Control Rate(DCR)(through study completion, an expected average of 4.5 year.)
- [Phase II&III] Quality of life(QoL)(C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.)
- Incidence of Treatment-Emergent Adverse Events [Safety](Up to 28 days after last investigational product administraion.)
研究者
研究点 (51)
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