Clinical trial · Observational
Study to Determine the Utility of FES-PET and FDG-PET in the Prediction of Response to Hormone Therapy in Women With Estrogen Positive Metastatic Breast Cancer
For Women With Estrogen Positive Metastatic Breast Cancer Discordance of Pre-treatment FDG-PET and FES-PET in Addition to Presence of Ki-67 and Human Epidermal Growth Factor 2 (HER-2) Overexpression Will Predict for Hormone Refractory Disease When Compared to Standard Response Criteria
- 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)
This study of hormone positive (estrogen receptor \[ER\]), metastatic invasive ductal breast cancer looks at functional scanning using positron emission tomography (PET) and patient response to hormone therapy. Functional scans allow investigators to see more than one metastatic location. The investigators will use an estrogen based agent (FES) to see the number of hormone positive metastases and compare that to positive lesions on routine glucose (FDG) based scanning. FES and FDG-PET results will be compared to give a FDG to FES ratio. The PET ratio will be calculated before hormone therapy and at relapse after treatment. The investigators will biopsy an accessible lesion that is FDG positive and FES negative and perform pathological testing for ER and PR positivity and compare it to the original primary tumor ER/PR. The investigators will test the lesion for tumor proliferation (using Ki-67) and aggressiveness using human epidermal growth factor receptor 2 (HER-2). Results will be compared to the primary tumor Ki-67 and HER-2 to determine concordance. The investigators will have pre-treatment results for FES and FDG-PET, will calculate the ratio, and will correlate it to the primary metastatic lesion and test for ER/PR, Ki-67, and HER-2, and subsequent response to therapy. The investigators will determine the FES-PET predictive value for determining appropriateness of hormone therapy for metastatic disease. With these results, the investigators plan to undertake future tumor biomarker/PET studies in 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 (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic invasive ductal ER positive breast cancer * All adjuvant treatment must have been completed at least 3 months prior to study entry. Exclusion Criteria: * Patients who do not have the primary tumor subtype of invasive ductal adenocarcinoma * Patients with only loco-regional recurrence
References
Publications (0)
Data not yet available