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

NCT ID: NCT05797987

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biyun Wang, MD

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38107829 (View on PubMed)

Other Identifiers

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YOUNGBC-25

Identifier Type: -

Identifier Source: org_study_id

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