Negative ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-positive Primary Tumor

February 23, 2024 updated by: Biyun Wang, MD, Fudan University

Negative Estrogen Receptor (ER) Expression Assessed by 18F-fluoroestradiol Positron Emission Tomography/Computed Tomography (18F-FES PET/CT) in the Metastatic Breast Cancer (MBC) With ER-positive Primary Tumor

To investigate the treatment pattern and efficacy of patients with positive primary ER lesion but negative ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Biyun Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MBC patients with ER-positive primary tumor who detected negative ER expression in metastatic disease using 18F-FES PET/CT at the Fudan University Shanghai Cancer Center

Description

Inclusion Criteria:

  • Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
  • MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2010 and 2022
  • Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage

Exclusion Criteria:

  • Patients with incomplete medical records and those diagnosed with secondary primary tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FES negative in MBC
Patients who did not present with any ER-positive lesions were characterized as with negative ER expression in the metastatic stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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