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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05797987

Enrollment

Registered

2023-04-04

Start date

2022-12-01

Completion date

2023-08-01

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	6 weeks

Secondary

Measure	Time frame	Description
Adverse events	6 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

Countries

China

Outcome results