Clinical trial · Interventional
Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer
Evaluation Study of the Prediction of the Response to Second-line Hormone Therapy by 16α- [18F] Fluoro-17β-estradiol (FES) PET in Patients With Metastatic Breast Cancer
- 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)
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas. Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.
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 |
|---|---|---|---|
| FES PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FES PET/CT
- description
- The images will be made immediately after the injection of the FES in a dynamic acquisition, of 30 minutes, centered on a positive FDG lesion. The imaging will then be completed 1 hour after the injection, after obtaining a urination, by an acquisition "whole body" (from the top of the skull to the root of the thighs or more if element on FDG or conventional imaging) which will be performed in the supine position with arms around the body. During the PET / CT scan, patients will breathe spontaneously. The acquisition will last 30 minutes.
- interventionNames
- Diagnostic Test: FES PET/CT
Primary outcomes (1)
- measure
- Determine the predictive value of PET at the "lesion" level
- timeFrame
- 6 weeks
- description
- Determine the predictive value of PET at the "lesion" level, before a second-line hormonal treatment on the response obtained at 6 weeks of treatment.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2, 2. Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury, 3. Patient progressing under a 1st line of hormone therapy, 4. Patient candidate for a new second-line hormonal treatment, 5. Postmenopausal patient, 6. Karnofsky ≥ 70 or ECOG 0-1 7. Life expectancy of at least 6 months 8. Creatinine \<= 2.5 normal 9. Social insured patient 10. Signed informed consent Exclusion Criteria: 1. HER2 overexpressing primary tumor in immunohistochemistry, 2. Tumor that does not significantly (\<10%) express the hormonal receptors, 3. Hormonal treatment in progress, 4. Contraindication to a new second-line hormonal treatment, 5. Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer, 6. Persons deprived of liberty or guardianship, 7. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons, 8. Serious illness or comorbidity assessed at risk, 9. History of cancer within 5 years, with the exception of cutaneous carcinomas other than melanomas, or carcinoma in situ of the cervix, 10. Intellectual inability to sign informed consent.
References
Publications (0)
Data not yet available