EUCTR2012-003679-21-DE进行中（未招募）1 期
A multicenter site, open label, phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer - Neo-PREDICT-HER2
Westdeutsche Studiengruppe GmbH0 个研究点目标入组 80 人开始时间: 2012年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •1.Female patients, age at diagnosis 18 - 75 years
- •2.Histological confirmed unilateral primary invasive carcinoma of the breast
- •3.Clinical cT1 (> 1 cm) - cT4 (if operable, inflammatory breast cancer is excluded)
- •4.HER2 over-expressing tumor confirmed by: 3+ by Immunohisto-chemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization [FISH, CISH or SISH; >6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of = 2.0]
- •5.Clinically node positive disease or node negative disease
- •6.No clinical evidence for distant metastasis (cM0) after conventional staging
- •7.Performance Status ECOG = 1 or KI = 80%
- •8.Baseline LVEF > 50% measured by echocardiography
- •9.Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- •10.The patient must be accessible for treatment and follow-up
- •11.Written informed consent including a written informed consent for shipping of tumor block for central pathology review and evaluation prior to the start of any study procedures
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1.Known hypersensitivity reaction to the compounds or incorporated substances
- •2.Known polyneuropathy grade = 2
- •3.Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment).
- •4.Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- •5.Prior or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •6.Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
- •7.Male breast cancer
- •8.Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •9.Breast feeding women
- •10.Sequential breast cancer
- •11.Lack of patient compliance
- •12.Inadequate organ function including:
- •Leucocytes < 3.5 x 109/l
- •Platelets < 100 x 109/l
- •Absolute Neutrophil Count (ANC) < 1.5 x 109/l
- •Hemoglobin < 9 g/dl
- •Serum Creatinine > 2.0 x ULN1.5 mg/dl
- •Serum Bilirubin > 1.1 mg/dl
- •Alkaline phosphatase > 2.5 x ULN
- •ASAT and/or ALAT > 2.5 ULN
- •Albumin < 2.5 g/dl
- •13.Uncompensated cardiac function
- •14.Malabsorption syndrome, disease significantly affecting gastrointestinal function
- •15.Concomitant use of CYP3A4 inhibitors or inducers
研究者
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