Metastatic Breast Cancer
Conditions
Keywords
PET/CT,fluoroestradiol (18F), breast cancer, metastatic, prediction of response, hormone therapy
Brief summary
Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.
Detailed description
Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Secondary objectives: * evaluate diagnostic performance of FES PET/CT * determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient * precise the nature of discordant FES/FDG foci * validate and improve the interpretation criteria for FES PET/CT * confirm the perfect tolerance
Interventions
2-4 MBq/kg body mass, one single IV injection
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 17 * WHO 0-2 * Metastatic adenocarcinoma of the breast * Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment * Life expectancy \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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. | at 6 months | Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient. |
Secondary
| Measure | Time frame |
|---|---|
| Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. | at 6 months |
Countries
France
Outcome results
None listed