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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01627704
Eligibility Criteria:
Inclusion Criteria:
* Post menopausal
* age \> 17
* WHO 0-2
* Metastatic adenocarcinoma of the breast
* Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
* Life expectancy \> 6 months
* Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
* Presence of oestrogen receptors proven with immunohistochemistry (\> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
* Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
* FDG PET/CT available on PACS or CD DICOM III format 11
* Informed consent obtained
Exclusion Criteria:
* Other evolutive malignant disease or acute or chronic infectious disease
* Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
* Isolated liver metastasis (high FES uptake by normal liver)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01627704
Study Brief:
Protocol Section:
NCT01627704