Androgen receptor and estrogen receptor imaging in metastatic breast cancer patients
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON39731
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Metastatic breast cancer, with at least one known metastasis outside of the liver
2. Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
3. Postmenopausal status defined as one of the following:
a. age >=60 years
b. previous bilateral oophorectomy
c. age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
d. patients age <60 years using an ER-antagonist should have amenorrhea for > 12 months and FSH >24 U/L and LH >14 U/L
e. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
4. Initially ER-positive tumor histology.
5. ECOG performance status 0-2.
6. Signed written informed consent
7. Able to comply with the protocol
1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
2. Life-expectancy <= 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The sensitivity and specificity of FDHT PET and FES PET to visualize and<br /><br>quantify AR- and ER-expression respectively, when compared to<br /><br>imunnohistochemistry on the biopsied metastasis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- the heterogeneity of FDHT and FES uptake among metastases within an<br /><br>individual patient, as well as the inter-patient differences.<br /><br>- interobserver variation in PET interpretation between two independent<br /><br>observers from both study sites (VUMC and UMCG)</p><br>