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NCT Number: NCT07316439

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-Free Survival

    Time frame: 6 weeks

Secondary outcomes

  1. Overall Response Rate

    Time frame: 6 weeks

  2. Disease Control Rate

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Clinical Outcomes of ER-Positive to Negative Conversion Versus Triple-Negative Breast Cancer (TNBC): Evidence From a 18F-fluoroestradiol Positron Emission Tomography/Computed Tomography (18F-FES PET/CT) Guided Propensity-Score-Matched Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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