EUCTR2020-000981-41-AT进行中（未招募）1 期
Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases
Med. Univ. Wien, Klinik f. Innere Mdizin I, Onkologie0 个研究点目标入组 15 人开始时间: 2020年5月13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
- 15
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
- All
入选标准
- •Histologically confirmed breast cancer
- •Radiologically documented metastatic disease
- •HER2-positive as defined by IHC 3+ and/or HER2/neu gene amplification
- •Newly diagnosed brain metastases or brain metastases progressing after prior local therapy
- •Measurable disease (RANO-BM criteria)
- •No indication for immediate local treatment
- •No indication of leptomeningeal disease
- •KPS >70%, ECOG <2
- •Indication for systemic anti-HER2 treatment
- •Prior exposure to trastuzumab and pertuzumab
- •Prior exposure to T-DM1 allowed
- •Life expectancy of at least 3 months
- •Age =18 years
- •Patient must be able to tolerate therapy, and have adequate cardiac function (defined by baseline left ventricular ejection fraction =50%)
- •Adequate bone-marrow, liver and kidney function
- •Adequate treatment washout period before enrolment, defined as:
- •Major Surgery: =4 weeks
- •Radiation therapy: =4 weeks
- •Chemotherapy, small-molecule targeted agents, anticancer hormonal therapy: =3 weeks
- •Antibody-based treatment: =4 weeks
- •Patient must be capable of understanding the purpose of the study and have given written informed consent
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Metastatic breast cancer other than HER2-positve disease
- •Use of any investigational agent within 28 days prior to initiation of treatment
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Indication for immediate local therapy by local standard
- •Leptomeningeal involvement
- •Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment
- •Concomitant radiotherapy
- •Prior radiotherapy to the thorax other than breast irradiation or irradiation of bone metastases
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction <50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450 ms)
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) including acute and chronic infections with hepatitis B and C
- •Inadequate haematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands) <1.0 x 109/L; platelets <100 x 109/L
- •Inadequate kidney function: serum-creatinine >1.5 times upper normal limit
- •Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (>3 in patients with liver metastases or known history of Gilbert’s disease); ALT, AST >3 times upper normal limit (>5 in patients with liver metastases); serum albumin <2.5 g/dL; INR =1.5
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), or prior pneumonectomy
- •Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
- •Patients with active opportunistic infections
- •Known HIV infection
- •Pregnant or lactating women. Women with childbearing potential must have a negative pregnancy test at screening
- •Women with childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Acceptable contraception methods included the application of an intrauterine device, barrier method or total abstinence
- •Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
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