Clinical trial · Interventional
Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer
Fluorine-18 Fluoroestradiol Positron Emission Tomography-computed Tomography: an in Vivo Biomarker Predicting Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer?
NCT03507088CI-TRIAL-00038524completedN/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)
Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer
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
- EXPERIMENTAL
- label
- fulvestrant
- description
- 500mg fulvestrant on days 0, 14, 28 and every 28 days thereafter Fluoroestradiol-PET is performed at baseline and after 28 days
- interventionNames
- Drug: Fluoroestradiol (18F)
Primary outcomes (1)
- measure
- To evaluate the accuracy of the change of FES uptake in predicting progression-free survival(PFS) in patients treated with fulvestrant 500 mg
- timeFrame
- baseline; 28 days
- description
- The FES-uptake will be calculated for all tumor lesions in individual patient at baseline and 28 days. Therapy response will be monitored by regular follow-up. RECIST criteria and clinical benefit will be used as criteria. All patients will be followed up until disease progression.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence. 2. No previous fulvestrant treatment 3. ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed. 4. Age \> 18 5. ECOG 0-2 6. Life expectancy \> 6 months 7. Informed consent obtained 8. Able to comply with the protocol Exclusion Criteria: 1. Presence of life-threatening visceral metastases 2. Evidence of central nervous system metastases 3. \> 3 lines of endocrine therapy for metastatic disease 4. Isolated liver metastasis (high FES uptake by normal liver)
References
Publications (0)
Data not yet available
No reference posted for this study.