Comparison Between ER Loss and Triple-Negative Breast Cancer Guided by 18F-FES PET/CT in Metastatic Breast Cancer

NCT ID: NCT07316439

Last Updated: 2026-01-05

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

ACTIVE_NOT_RECRUITING

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-06-05

Brief Summary

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This study aimed to compare survival outcomes and clinical characteristics between ER loss and metastatic triple-negative breast cancer (mTNBC) patients, exploring the prognostic implications of dynamic ER changes.

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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ER negative conversion group

82 patients with functional ER loss detected by FES-PET at metastatic sites before first-line treatment

No interventions assigned to this group

mTNBC

A total of 115 contemporaneous patients with metastatic TNBC at initial diagnosis

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 2017 and 2023
* Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage
* Contemporaneous patients with metastatic TNBC at initial diagnosis

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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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YOUNGBC-36

Identifier Type: -

Identifier Source: org_study_id

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