NCT03048942已完成2 期
A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer
University Hospitals Bristol and Weston NHS Foundation Trust22 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2014年12月18日最近更新:
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
- 158
- 试验地点
- 22
- 主要终点
- Progression free survival
研究概览
简要总结
90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.
详细描述
This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease
- •Measurable disease as per RECIST 1.1
- •HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration<2.0) in the case of IHC 2+
- •ECOG performance status 0 or 1
- •ER+ve or ER-ve
- •Female age ≥18 years
- •Anticipated life expectancy > 6 months
- •Haemoglobin >10.0g/DL
- •Absolute neutrophil count>1.5 x 10^9/L
- •Platelet count>100 x 10^9/L
- •ALT/SGPT<1.5 X ULN
- •Serum creatinine <1.5 x ULN
- •Negative pregnancy test for all women of child bearing potential
排除标准
- •Grade ≥2 oral mucositis or peripheral or sensory neuropathy
- •History of other malignancy
- •History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes
- •Clinically significant cardiovascular disease
- •Any acute or chronic medical condition
- •Acute infection requiring systemic antibiotics or antifungal medication
- •Sex hormones
- •Administration of any live vaccine within 8 weeks
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
- •Participation in another clinical trial with an investigational drug within 30 days of randomisation
- •Pregnant or breast feeding women
- •Contraindications to the use of corticosteroid treatment
- •HER2 Positive breast cancer
- •Previous Paclitaxel chemotherapy in the adjuvant setting
- •Previous cytotoxic chemotherapy for metastatic disease
- •Palliative radiotherapy for metastatic disease within 4 weeks of randomisation
- •Symptomatic brain metastases confirmed with CT/MRI brain
- •History of other malignancy
研究组 & 干预措施
Cabazitaxel
Experimental
6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
干预措施: Cabazitaxel (Drug)
Paclitaxel
Active Comparator
6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression free survival
时间窗: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Duration of progression free survival
Progression Free Survival
时间窗: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Duration of progression free survival
次要结局
- Objective response rate(At completion of 6 cycles of chemotherapy, which is after 18 weeks.)
- Overall survival(Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.)
- Time to next chemotherapy treatment(Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.)
- Number of adverse events and Number of participants with adverse events per arm and the grade of AEs(Form the date of consent to 30 days after trial treatment has stopped.)
- Clinical benefit rate(At the completion of 6 cycles of chemotherapy, which is after 18 weeks)
- Time to response(Determined by time from randomisation to radiological partial response, usually within the 6 cycles of treatment, therefore wihtin 18 weeks.)
- Quality of life as measured by patients themselves(EQ5D-5L and FACT B will be completed at baseline, prior to cycles 3 and 5 and at the end of treatment visit, therefore within approximately 21 weeks from randomisation)
- Clinical Benefit Rate(At the completion of 6 cycles of chemotherapy, which is after 18 weeks)
- Objective Response Rate(At completion of 6 cycles of chemotherapy, which is after 18 weeks.)
- Overall Survival(Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.)
- Time to Next Chemotherapy Treatment(Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.)
- Time to Response(Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.)
- Assessment of EQ-5D-5L Questionnaire(EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks))
- Assessment of EQ-5D-5L VAS Score(EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks))
- Assessment of FACT-B Questionnaire(EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks))
研究者
研究点 (22)
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