Skip to content

Moleculaire beeldvorming van de oestrogeenreceptor dichtheid om de hormonale behandelingsmogelijkheden voor patiënten met borstkanker te verbeteren.

Imaging of ER density to guide and improve tailored therapy for acquired anti-hormonal resistant breast cancer.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26431
Enrollment
50
Registered
2010-03-01
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer acquired anti-hormonal resistance

Interventions

In patients with acquired antihormonal resistance, eligible for estrogen therapy, a FES-PET scan will be made to determine FES-PET tumor uptake (which corresponds to estrogen receptor expression level

Sponsors

University Medical Center Groningen (UMCG), department of medical oncology
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactG.A.P. Hospers

Dept. of Medical Oncology University Medical Center Groningen PO Box 30.001

g.a.p.hospers@int.umcg.nl+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)