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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05797987
• Lead Sponsor: Fudan University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	6 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

Trial Locations

Locations (1)

Biyun Wang, MD; 🇨🇳 Shanghai, Shanghai, China