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OpenTrials
Completed

NCT Number: NCT05797987

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

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).

Completed

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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

Biyun Wang, MD

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 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

Treatment and study plan

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 6 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 6 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Feb 26, 2024

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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