NCT07316439

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Dec 2024Jun 2026

Study Start

First participant enrolled

December 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Expected
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    6 weeks

Secondary Outcomes (2)

  • Overall Response Rate

    6 weeks

  • Disease Control Rate

    6 weeks

Study Arms (2)

ER negative conversion group

82 patients with functional ER loss detected by FES-PET at metastatic sites before first-line treatment

mTNBC

A total of 115 contemporaneous patients with metastatic TNBC at initial diagnosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin 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

December 19, 2025

First Posted

January 5, 2026

Study Start

December 31, 2024

Primary Completion

June 5, 2025

Study Completion (Estimated)

June 5, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

CN(1)