Clinical Trial · NCT01986569

Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer

Overview

The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and determination of tumor estrogen status according to National Comprehensive Cancer Network and European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most commonly used method for determining ER status. A investigational imaging tracer named 16-alpha-\[18F\]-fluoro-17-beta-estradiol, or \[18F\]fluoroestradiol (\[18F\]FES) acts similarly in vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have shown the efficacy of \[18F\]FES PET in detecting ER positive breast cancer without any observed toxicity. The investigators hypothesized that \[18F\]FES PET imaging can noninvasively assess ER status in recurrent or metastatic breast cancer lesion . In this study, a positive and negative percent agreement between IHC and \[18F\]FES will be determined.

Sponsor

Asan Medical Center

Phase

Phase 3

Contacts

Dae Hyuk Moon, MD. PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01986569

Drug / Compound

fluoroestradiol

Isotope(s):

Target(s):

Estrogen Receptor

Ligand Class: Small Molecules

Eligibility

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
A patient will be enrolled if the patient meets the following inclusion criteria
Patients had histologically confirmed invasive primary breast carcinoma and the documented results of histology are available.
Patients are scheduled to undergo core needle biopsy or surgery for histological confirmation and determination of ER status of recurrent or distant metastatic cancer within 15 days after \[18F\]FES PET; or patients already underwent core needle biopsy of recurrent or distant metastatic cancer within 30 days before \[18F\]FES PET and biopsy specimens are available for determination of ER status.
Patients has first recurrence or stage IV disease by American Joint Committee on Cancer tumor-node-metastasis staging system for breast cancer
Discontinuation of selective ER blocking agents including tamoxifen or fulvestrant for at least 60 days prior to \[18F\]FES PET

Exclusion

The recurrent or metastatic lesion scheduled to undergo biopsy is located in breast, liver, ovary, uterus, or bone
Adjuvant chemotherapy within 3 weeks prior to \[18F\]FES PET.
Patient has any other condition or personal circumstances that, in the judgment of the investigator, might interfere with the collection of complete data
A patient will be excluded from this study if the patient does not full fulfill the inclusion criteria, or if any of the following conditions are observed
Radiation therapy or immuno/biologic therapy is scheduled to be given to patient before the histologic confirmation by biopsy or \[18F\]FES PET.
Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) in the judgment of the investigator.
Patient is a relative of the investigator, student of the investigator or otherwise dependent
Female patient is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) woman is physiologically post menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]FES has to be negative and the women is advised to apply contraceptive measures during her participation in this study
Patient has been involved in an investigative, radioactive research procedure within 7 days prior to registration