metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence. 2. Post-menopausal status (age >= 45 years with amenorrhea for > 12 months [with or without concomitant use of LHRH-/GNRH-agonists]or prior bilateral ovariectomy 3. Documentation of a negative pregnancy test must be available for women less than 2 years after menopause 4. Progressive disease after 2 lines of hormonal therapy 5. No previous fulvestrant treatment 6. ER-antagonists should be discontinued for 5 weeks prior to FES-PET to prevent false negative FES_PET results, the use of aromatase inhibitors prior to FES-PET is allowed. 7. At least one measurable lesion according to RECIST v1.1 that is localized outside of the liver 8. ECOG performance status 0, 1 or 2 9. Life expectancy > 3 months 10. Creatinine clearance >= 30 ml/min 11. Age >= 18 years 12. Signed written informed consent 13. Able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Evidence of central nervous system metastases 2. Presence of life-threatening visceral metastases 3. > 3 lines of endocrine therapy for metastatic disease 4. > 2 lines of chemotherapy in metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute and relative changes in tracer uptake values during fulvestrant therapy (after 1 month and 3 months) compared to tracer uptake prior to fulvestrant therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between tumor response and absolute and relative changes in tracer uptake | — |
Countries
Netherlands
Outcome results
None listed