Positive ER Expression Assessed by 18F-FES PET/CT in the MBC with ER-negative Primary Tumor

NCT06344767 | Completed

• 1 other identifier: YOUNGBC-27
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival

  6 weeks

Secondary Outcomes (1)

• Adverse events

  6 weeks

Study Arms (1)

FES positive in MBC

Patients who did not present with any ER-positive lesions in primary cancer were characterized as with any positive ER expression in the metastatic stage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MBC patients with ER-negative primary tumor who detected positive ER expression in metastatic disease using 18F-FES PET/CT at the Fudan University Shanghai Cancer Center

You may qualify if:

• 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 nonmetastatic stage.
• MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2012 and 2023
• Patients diagnosed with primary ER-negative tumor and who were yet to receive any systemic therapy during the advanced stage

You may not qualify if:

• Patients with incomplete medical records and those diagnosed with secondary primary tumors

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

China,Shanghai

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: September 1, 2023
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

CN (1)