[89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; a multicentre study
- Conditions
- HER2 positive primary breast cancer
- Registration Number
- NL-OMON28319
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• 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.
• 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.
• Metastases 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 (~30 min)).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if HER2 positive primary breast cancer can be detected by [89Zr]trastuzumab PET/CT imaging, using histopathological examination as the gold standard, after neoadjuvant treatment.<br>- Assess the negative predictive value and sensitivity of [89Zr]trastuzumab PET/CT imaging to detect HER2 positive primary breast cancer.
- Secondary Outcome Measures
Name Time Method - Assess agreement between [89Zr]trastuzumab PET/CT-imaging signal in the tumor and axilla, histopathologic evidence of tumor and HER2 expression.<br>- Assess the agreement between different imaging modalities ([89Zr]trastuzumab PET/CT-scan, [18F]FDG-PET/CT and MRI).<br>- Determine the feasibility to image HER2 positive primary breast cancer using preoperatively PET/CT imaging and a HER2 targeting tracer