Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01832051
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
* HER2 immunohistochemical score of 3+, or
* HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
* in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
* in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
4. Age \>18 years of age.
5. WHO performance status 0-2.
6. Signed written informed consent.
7. Able to comply with the protocol.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
3. Inability to comply with study procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01832051
Study Brief:
Protocol Section:
NCT01832051