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Recurrent Breast CancerPhase 3NCT01986569

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

A Phase 3 study testing [18F]fluoroestradiol (FES) in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
[18F]fluoroestradiol (FES)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSouth Korea
Study dates
Nov 2013to Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient will be enrolled if the patient meets the following inclusion criteria
  • 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

Who cannot join

  • 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
  • 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
  • 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
  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase III, Open Label, Non-randomized, Single Center Study to Evaluate Diagnostic Accuracy and Safety of Fluorine-18 (18F) Fluoroestradiol PET/CT in the Assessment of ER Status of Recurrent or Metastatic Lesions in Patients With Breast Cancer

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.

Being tested
[18F]fluoroestradiol (FES)
Keywords
Fluoroestradiol (FES), PET/CT scan, Estrogen Receptor, Recurrent breast cancer, Stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [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.

Study groups in NCT01986569
Study groupRoleWhat they receive
[18F]fluoroestradiol (FES)ExperimentalThe injectable radioactive dose of 111-222 megabecquerel. One single IV injection over 1-2 min. [18F]FES PET/CT for imaging.
Receives: Drug: [18F]fluoroestradiol (FES)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986569
Sponsor's protocol ID
FES13001
Status last verified
Dec 2016
First submitted
12 Nov 2013
Last updated
8 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30846327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [18F]fluoroestradiol (FES) in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lesion-level positive and negative percent agreement between qualitative [18F]FES PET interpretation and reference IHC testing (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.

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