AR and ER Imaging in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988324
• Other study ID #: 2012.2708
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• FDHT-PET scan

• FES-PET scan

• CT-scan

• Bone scintigraphy

• Tumor biopsy

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity/ specificity	The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.	within two months
Secondary	Accuracy	The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.	within six weeks
Secondary	Inter- and intra-patient variation	Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.	within six weeks
Secondary	Inter-observer variation	Inter-observer variation in FES PET and FDHT PET results in two independent observers.	approximately two months