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

NCT01986569 | Completed Phase 3 DMC

• 1 other identifier: FES13001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Breast Cancer; Stage IV Breast Cancer

Keywords

Fluoroestradiol (FES); PET/CT scan; Estrogen Receptor; Recurrent breast cancer; Stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• lesion-level positive and negative percent agreement between qualitative [18F]FES PET interpretation and reference IHC testing

  up to 3 years

Study Arms (1)

[18F]fluoroestradiol (FES)

EXPERIMENTAL

The injectable radioactive dose of 111-222 megabecquerel. One single IV injection over 1-2 min. \[18F\]FES PET/CT for imaging.

Drug: [18F]fluoroestradiol (FES)

Interventions

[18F]fluoroestradiol (FES) DRUG

\[18F\]FES PET/CT will be performed 90 min (± 10 min) after administration of \[18F\]FES. Patients will undergo core needle biopsy or surgery within 15 days after \[18F\]FES PET; or patients will undergo core needle biopsy within 30 days before \[18F\]FES PET. Experienced pathologists will determine metastatic/recurrent disease, and tumor histology including IHC. Patient will undergo surgery, radiation therapy or systemic therapy according to the results of staging workup, histology and biomarkers.

[18F]fluoroestradiol (FES)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥19 years of age and male or female of any race/ethnicity
• Patients has first recurrence or stage IV disease by American Joint Committee on Cancer tumor-node-metastasis staging system for breast cancer
• 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.
• Discontinuation of selective ER blocking agents including tamoxifen or fulvestrant for at least 60 days prior to \[18F\]FES PET
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

You may not qualify if:

• Patient or patient's legally acceptable representative do not provide written informed consent
• 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.
• 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
• Patient has any other condition or personal circumstances that, in the judgment of the investigator, might interfere with the collection of complete data
• Patient has been involved in an investigative, radioactive research procedure within 7 days prior to registration

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Chae SY, Ahn SH, Kim SB, Han S, Lee SH, Oh SJ, Lee SJ, Kim HJ, Ko BS, Lee JW, Son BH, Kim J, Ahn JH, Jung KH, Kim JE, Kim SY, Choi WJ, Shin HJ, Gong G, Lee HS, Lee JB, Moon DH. Diagnostic accuracy and safety of 16alpha-[18F]fluoro-17beta-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. Lancet Oncol. 2019 Apr;20(4):546-555. doi: 10.1016/S1470-2045(18)30936-7. Epub 2019 Mar 4.

  PMID: 30846327 DERIVED

Related Links

• Genetics Home Reference related topics; breast cancer
• MedlinePlus related topics; Breast cancer

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dae Hyuk Moon, MD. PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

KR (1)