AR and ER Imaging in Metastatic Breast Cancer

Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Other: FDHT-PET scan; Other: FES-PET scan; Other: CT-scan; Other: Bone scintigraphy; Other: Tumor biopsy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU Medical Center
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES/FDHT-PET	Other: FDHT-PET scan; Other: FES-PET scan; Other: CT-scan; Other: Bone scintigraphy; Other: Tumor biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.	within six weeks
Inter- and intra-patient variation	Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.	within six weeks
Inter-observer variation	Inter-observer variation in FES PET and FDHT PET results in two independent observers.	approximately two months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimated): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2012.2708