Clinical trial · Interventional
PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
A Phase II Clinical Trial to Evaluate 18F-Fluoroestradiol Positron Emission Tomography / Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Purpose: To determine whether \[18F\]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for further hormonal therapy.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline | Procedure | — | UNRESOLVED |
| Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up | Procedure | — | UNRESOLVED |
| Diagnostic Imaging: 18F-FES PET/CT - Baseline | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT Guided FES Therapy
- description
- All subjects will be seen at baseline and then monthly until month 6 of fulvestrant therapy unless clinical or radiological progression or unacceptable toxicity earlier than month 6.
- interventionNames
- Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline
- Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline
- Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up
Primary outcomes (1)
- measure
- Clinical Benefit Rate (CBR)
- timeFrame
- 24 weeks
- description
- CBR is defined as a patient having a best overall response of a complete response (CR), partial response (PR), or stable disease for at least 24 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for \> 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy) * hormone receptor positive (ER and/or PgR) disease as determined locally * WHO performance status 0-2 * life expectancy of ≥ 3 months * the presence of at least one measurable or evaluable (non-measurable) lesion * informed consent prior to any study procedures Exclusion Criteria: * life threatening metastatic visceral disease * brain or leptomeningeal metastases * prior exposure to fulvestrant * history of bleeding diathesis or need for long term anti-coagulation
References
Publications (0)
Data not yet available