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

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05797987
Collaborator
(none)
52
Enrollment
1
Location
5
Anticipated Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    52 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    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
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [6 weeks]

    Secondary Outcome Measures

    1. Adverse events [6 weeks]

      Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biyun Wang, MD Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biyun Wang, MD, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05797987
    Other Study ID Numbers:
    • YOUNGBC-25
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 7, 2023