Negative ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-positive Primary Tumor
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
1 other identifier
observational
52
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 26, 2024
February 1, 2024
8 months
March 22, 2023
February 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
6 weeks
Secondary Outcomes (1)
Adverse events
6 weeks
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients with incomplete medical records and those diagnosed with secondary primary tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Biyun Wang, MD
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
You S, Xie Y, Ji M, Liu C, Zhao Y, Gong C, Hu S, Li Y, Yang Z, Wang B. ER status conversion and subsequent treatment: an assessment of negative ER expression detected by 18F-FES PET in metastatic breast cancer patients with ER-positive primary tumors. Ther Adv Med Oncol. 2023 Dec 15;15:17588359231216093. doi: 10.1177/17588359231216093. eCollection 2023.
PMID: 38107829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 4, 2023
Study Start
December 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
February 26, 2024
Record last verified: 2024-02