A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents.
Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with feasible toxicity for MBC patients as a salvage treatment strategy after failure of anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with other salvage agents, especially for patients with HER2 overexpression breast cancers. Additionally, a recent report showed that possible rational background for patients with HER2 mutation-positive breast cancers.
Based on this rationale, the investigators are to conduct phase II single-arm study of poziotinib for patients with MBC who showed refractoriness to conventional treatments as salvage treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 metastatic breast cancer with measurable or evaluable disease
- •age ≥ 20 years
- •HER2 mutation or EGFR mutation/gene amplification confirmed by CancerSCAN or Activated AR pathway confirmed by RNA seq & nCounter assay, AR expression was confirmed by immunohistochemistry(IHC) or EGFR high expression (≥ IHC 2+ & lower ER / ≥ IHC score + and HER2 2+ or SISH negative)
- •ECOG performance status 0 - 2
- •Two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane
- •Life expectancy ≥ 3 months
- •Progression within 6 months or less of latest chemotherapy
- •The patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiotherapy must be completed 2 weeks before study entry.
- •Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- •Adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or CCr ≥ 50 ml/min)
- •Adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, AST/ALT ≤ 3 x upper normal limit)
- •No prior history of pan-HER TKI including poziotinib for metastatic breast cancer
- •Written informed consent
排除标准
- •HER2-overexpressing breast cancer
- •Serious uncontrolled intercurrent infections
- •Serious intercurrent medical or psychiatric illness, including active cardiac disease
- •Pregnancy or breast feeding
- •Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
- •Documented leptomeningeal brain metastasis
- •Known brain metastases unless treated and stable
- •Peripheral neuropathy ≥ grade 3
- •Prior treatment with pan-HER TKI including poziotinib will not be allowed.
- •Use of any investigational drug within 4 weeks of the study
- •Treatment with chemotherapy or hormone therapy within 3 weeks of the study
研究组 & 干预措施
Poziotinib
12mg P.O. for 2wks q21days
干预措施: Poziotinib (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 1 years
次要结局
- overall survival (OS)(1 years)
- duration of response(1 years)
- objective response rate(1 years)
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability(1 years)
研究者
Yeon Hee Park
Professor
Samsung Medical Center