Clinical trial · Interventional
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?
NCT01627704CI-TRIAL-00019456ESTROTEPREDICcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoroestradiol (18F) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fluoroestradiol (18F)
- interventionNames
- Drug: Fluoroestradiol (18F)
Primary outcomes (1)
- measure
- Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.
- timeFrame
- at 6 months
- description
- 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 outcomes (1)
- measure
- Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers.
- timeFrame
- at 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 17 * WHO 0-2 * Metastatic adenocarcinoma of the breast * Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment * Life expectancy \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)
References
Publications (0)
Data not yet available
No reference posted for this study.