NL-OMON50044已完成2 期
[89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; a multicentre study - [89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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.
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.
- •Prior radiotherapy to the targeted breast.
- •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 (~30 min)).
研究者
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