AR and ER Imaging in Metastatic Breast Cancer

Phase 2CompletedNCT01988324

University Medical Center Groningen24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: within two months

Secondary Outcomes

Accuracy

The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.

Time frame: within six weeks

Inter- and intra-patient variation

Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

Time frame: within six weeks

Inter-observer variation

Inter-observer variation in FES PET and FDHT PET results in two independent observers.

Time frame: approximately two months