AR and ER Imaging in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Other: FDHT-PET scan; Other: FES-PET scan; Other: CT-scan; Other: Bone scintigraphy; Other: Tumor biopsy

• Registration Number: NCT01988324
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2014-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FES/FDHT-PET	Tumor biopsy	-
FES/FDHT-PET	Bone scintigraphy	-
FES/FDHT-PET	FDHT-PET scan	-
FES/FDHT-PET	CT-scan	-
FES/FDHT-PET	FES-PET scan	-

Primary Outcome Measures

Name	Time	Method
Sensitivity/ specificity	within two months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands