breast cancer acquired anti-hormonal resistance
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with the diagnosis of acquired anti-hormonal resistant advanced breast cancer showing progression after two or more lines of antihormonal treatment; 2. Treatment with estradiol will be started; 3. Age> 18 years; 4. ECOG performance status 0-2.
Exclusion criteria
Exclusion criteria: 1. Life Expectancy <3 months; 2. Uncontrolled CNS metastases; 3. History of thrombosis; 4. Uncontrolled hypercalcemia; 5. Treatment with any investigational drug within 30 days before start of study; 6. Serious uncontrolled concurrent illness, e.g. autoimmune disorders; 7. New York Hearth Association (NYHA) class III/IV congestive heart failure; 8. Dyspnea at rest due to any cause; 9. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause; 10. Women of childbearing potential unless a) surgically sterile or b) using adequate measures of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| With a ROC analysis we will determine the optimal sensitivity and specificity of FES-PET in relation with the standard uptake value (SUV) to predict response to estrogen therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To discriminate the acquired anti-hormonal resistant phenotypes in patients based on ER expression levels by FES-PET; 2) Correlation between SUV and response to therapy. | — |
Contacts
Dept. of Medical Oncology University Medical Center Groningen PO Box 30.001