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NCT06344767 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Positive 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- Negative Primary Tumor

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06344767
Other study ID # YOUNGBC-27
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 5, 2024

Study information
Verified date March 2024
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 19
Est. completion date May 5, 2024
Est. primary completion date May 5, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 nonmetastatic stage. - MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2012 and 2023 - Patients diagnosed with primary ER-negative 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China China,Shanghai Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) Progression free survival 6 weeks
Secondary Adverse events Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0 6 weeks
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