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Clinical Trials/NCT05797987
NCT05797987
Completed
Not Applicable

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

Fudan University1 site in 1 country52 target enrollmentDecember 1, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Fudan University
Enrollment
52
Locations
1
Primary Endpoint
Progression free survival (PFS)
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Biyun Wang, MD

Professor

Fudan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time Frame: 6 weeks

Secondary Outcomes

  • Adverse events(6 weeks)

Study Sites (1)

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