Clinical trial NCT01988324: AR and ER Imaging in Metastatic Breast Cancer
Official title: Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.


Eligibility criteria: Inclusion Criteria:

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:

   * age ≥60 years
   * previous bilateral oophorectomy
   * age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
   * 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

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity/ specificity
timeFrame: within two months
Secondary outcomes:
measure: Accuracy
timeFrame: within six weeks
measure: Inter- and intra-patient variation
timeFrame: within six weeks
measure: Inter-observer variation
timeFrame: approximately two months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Mammatas LH, Venema CM, Schroder CP, de Vet HCW, van Kruchten M, Glaudemans AWJM, Yaqub MM, Verheul HMW, Boven E, van der Vegt B, de Vries EFJ, de Vries EGE, Hoekstra OS, Hospers GAP, der Houven van Oordt CWM. Visual and quantitative evaluation of [18F]FES and [18F]FDHT PET in patients with metastatic breast cancer: an interobserver variability study. EJNMMI Res. 2020 Apr 19;10(1):40. doi: 10.1186/s13550-020-00627-z.