No registrations found.
ID
Source
Brief title
Health condition
HER2 positive primary breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
- Assess the negative predictive value and sensitivity of [89Zr]trastuzumab PET/CT imaging to detect HER2 positive primary breast cancer.
Secondary outcome
- Assess agreement between [89Zr]trastuzumab PET/CT-imaging signal in the tumor and axilla, histopathologic evidence of tumor and HER2 expression.
- Assess the agreement between different imaging modalities ([89Zr]trastuzumab PET/CT-scan, [18F]FDG-PET/CT and MRI).
- Determine the feasibility to image HER2 positive primary breast cancer using preoperatively PET/CT imaging and a HER2 targeting tracer
Background summary
This pilot study is a phase II, multicenter study in HER2 positive breast cancer patients. This study will assess the feasibility of detection of HER2 positive breast cancer by preoperative [89Zr]trastuzumab PET/CT imaging of the primary tumor. For this study 20 patients with HER2 positive breast cancer will be included. All patients will undergo standard-of-care treatment, with additionally pre- and after neoadjuvant chemotherapy [89Zr]trastuzumab PET/CT imaging. All patients will receive 50 mg [89Zr]trastuzumab 4 days prior to the pre-neoadjuvant [89Zr]trastuzumab PET/CT scan and 4 days prior to the post-neoadjuvant [89Zr]trastuzumab PET/CT scan. The negative predictive value and sensitivity of HER2-targeting PET will be determined. Validation will take place by histopathologic assessment of tissue to determine the presence (or absence) of tumor tissue and immunohistochemically assessment for tumor HER2 expression.
Study objective
Currently, there is no adequate non-invasive diagnostic modality to assess treatment response after neoadjuvant therapy in breast cancer patients. To adequately predict histological complete response, further optimization of non-invasive imaging approaches for response monitoring is crucial. For patients with a complete response to neoadjuvant treatment non-operative treatment might be an option.
Approximately 20% of breast cancers have an overexpression of the human epidermal growth factor receptor 2 (HER2), which can be selectively targeted by the monoclonal antibody trastuzumab. By labelling trastuzumab with a radiotracer ([89Zr]trastuzumab) preoperative imaging using positron emission tomography (PET/CT) is possible. In this feasibility study, we will validate the value of the preoperative [89Zr]trastuzumab PET/CT imaging to identify HER2 positive primary breast cancer and the possibility to predict pathological complete response.
Study design
End of the trial.
Intervention
Patients will receive standard-of-care treatment. In addition, all patients will receive an injection with [89Zr]trastuzumab 4 days before (pre-) and after neoadjuvant chemotherapy PET/CT imaging.
Inclusion criteria
• 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.
Exclusion criteria
• 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)).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7607 |
| Other | METC LUMC : P18.238 |