EUCTR2018-004247-23-NL进行中（未招募）1 期
[89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; A multicentre study
eiden University Medical Center0 个研究点目标入组 20 人开始时间: 2018年12月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Female patients aged 18 years or older.
- •Confirmed diagnosis of HER2 positive primary breast cancer (confirmed by immunohistochemical staining of preoperative core-needle biopsy of tumor tissue; IHC with strong intensity 3+ or fluorescence in situ hybridization (FISH)) and eligible for breast cancer surgery.
- •Tumor size = 5 mm (0.5 cm) diameter according to anatomical imaging data.
- •WHO performance score 0-2.
- •Patients planned for neoadjuvant therapy.
- •Female patients need to be either surgically sterile, post-menopausal or pre-menopausal and not pregnant. Pre-menopausal female patients who are not surgically sterile should also employ an effective method of birth control for at least one month post-dosing when it consists of a hormonal contraceptive method or IUD. For other contraceptive methods, premenopausal females who are not surgically sterile have to agree to use an effective method of contraception.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
- •Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •No metastasis or multifocal lesions.
- •Prior radiotherapy to the thorax.
- •Breast prosthesis in the target breast.
- •Unacceptable known (clinical significant) cardiovascular or pulmonary disease, renal or liver dysfunction.
- •Known hypersensitivity to drugs comparative to trastuzumab or drugs in the same class (immunoglobulins), or any of their excipients or to any component of [89Zr]trastuzumab.
- •Concomitant medication known to interact with trastuzumab.
- •Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of an PET/CT scan (~60 min)).
研究者
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