Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.
This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed, recurrent or metastatic breast cancer
- •HER2-negative
- •ECOG PS 0-2
- •Age ≥ 20 years
- •Anthracycline- and Taxane-pretreated
- •Wash-out period of 3 weeks for cytotoxic chemotherapy
- •Wash-out period of 2 weeks for hormone therapy or radiotherapy
- •measurable or non-measurable lesions by RECIST v1.1
- •Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
- •Adequate liver functions
- •Adequate renal functions : sCr≤1.5mg/dL
- •Subjects willing to follow study protocol
- •Informed consent before study entry
排除标准
- •More than 3 lines of chemotherapy for metastatic breast cancer
- •Pregnant or breastfeeding women
- •Previous exposure to Pemetrexed or Vinorelbine
- •Neuropathy (grade 2 or more)
- •Symptomatic CNS metastasis
- •History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)
- •Hypersensitivity to study medication or related drugs
- •Concomitant vaccination for yellow fever
研究组 & 干预措施
Pemetrexed + Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
- Pemetrexed (500 mg/m2, day 1)
- Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th.... cycle after then.)
- Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose
- Dexa 4mg po bid on D0-2
干预措施: Pemetrexed + Vinorelbine (Drug)
Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
干预措施: Vinorelbine (Drug)
结局指标
主要结局
progression free survival
时间窗: response assessment every 6 weeks, for up to 2 years
From date of first dose of study drug till the date of documented progression or death from any cause
次要结局
- duration of response(response assessment every 6 weeks, for up to 2 years)
- response rate(response assessment every 6 weeks, for up to 2 years)
- overall survival(up to 2 years)
研究者
Seock-Ah Im
Professor
Seoul National University Hospital