EUCTR2020-000824-21-BE进行中（未招募）1 期
An open label phase II study to evaluate neratinib for treatment and prevention of subsequent CNS event(s) in patients with brain metastasis of advanced HER2 positive breast cancer - NERABRAI
Institut Jules Bordet0 个研究点目标入组 125 人开始时间: 2021年8月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subjects must meet all of the following criteria in order to be eligible for this study:
- •1)Age = 18 years old
- •2)ECOG performance status = 2
- •4)Diagnosis : histologically or cytologically confirmed HER2-positive tumour status according to the ASCO-CAP guidelines (defined as a 3+ score on immunohistochemistry (IHC) and/or positive by in situ hybridisation (ISH)) with brain metastases, estrogen receptor and progesteron receptor status
- •Cohort 1: with CNS metastases pre-treated with local approaches for the previous CNS events and currently progressive but locally treated CNS metastasis
- •Cohort 2: with a first diagnosis of CNS metastases, asymptomatic or paucisymptomatic not needing immediate local therapy
- •Cohort 3: with confirmed LM defined as the presence of malignant cells in the CSF or combination of typical symptoms and MRI findings
- •5)Specific criteria for cohorts 1 and 2 only: Must have radiologically confirmed metastatic brain lesion by MRI measurable by RANO-BM criteria
- •6)Specific criteria for cohort 3 only: LM defined as the presence of malignant cells in the CSF or combination of typical symptoms and MRI findings for cohort 3
- •7)Subjects should have received at least 1 previous line for the metastatic disease including taxanes based chemotherapy in combination with trastuzumab and pertuzumab (if available) unless contraindicated. Prior tucatinib is not an exclusion criteria.
- •8)Corticosteroids may be used as long as subjects are on a stable or decreasing dose for at least 7 days prior to study enrolment
- •9)Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to first neratinib administration
- •10)Women of childbearing potential must agree to use 1 highly effective or 2 effective methods of contraception (as defined at the protocol section 6.8.1) during the course of the study and at least 7 months after the last administration of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1)CNS disease requiring immediate neurosurgical intervention (e.g. resection, shunt placement, etc.)
- •2)Any unresolved toxicity = CTCAE grade 2 (except alopecia) from previous anti-cancer therapy
- •3)Is ineligible for or has already received all chemotherapy options among the physician’s choice
- •4)Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease
- •5)Specific criteria for cohort 2 only: Previous local treatment for CNS metastases
- •6)Specific criteria for cohort 2 only: Oligometastatic disease restricted to the CNS and for which a local treated is considered as the most appropriate treatment by the investigator. 7)Known DPD deficiency* tested by measuring the level of uracil in the blood, or by checking for the presence of certain mutations in the gene for DPD according to EMA recommendation in case investigator’s choice is capecitabine
- •8)Received an investigational anti-cancer drug within four weeks or five half-lives (whichever is shorter) of study drug administration
- •9) Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs
- •10)Known HIV, Hepatitis B or Hepatitis C infection
研究者
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