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CompletedNCT05392985Updated Feb 26, 2024

Detection and Analysis of MBC With Heterogeneous ER Expression

An observational study in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
51
Ages
18 Years and older
Sex
Female
01

Study summary

To investigate the treatment pattern and efficacy of MBC patients with ER heterogeneity using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 51 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Inclusion criteria

  • Patients received 18F-FES PET/CT in Fudan University Shanghai Cancer Center from 2017-2021.
  • Patients had both FES positive (FES+) and negative (FES-) lesions in FES exam.
  • Patients received further treatment.

Exclusion criteria

Exclusion Criteria:

  • Incomplete medical records.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • FES+-

    MBC patients with both FES positive(+) and negative(-) lesions.

06

What researchers measure

Primary outcomes

  1. PFS

    Progression free survival

    Time frame: 6 weeks

Secondary outcomes

  1. Adverse events

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

    Time frame: 6 weeks

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05392985
Lead sponsor
Fudan University
Responsible party
Biyun Wang, MD (Professor, Fudan University) — Principal investigator
First posted
May 26, 2022
Start date
Jan 15, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Feb 26, 2024

Study contacts

Biyun Wang
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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