Comparison Between ER Loss and Triple-Negative Breast Can... | NCT07316439

Studies
Comparison Between ER Loss and Triple-Negative Breast Cancer Guided by 18F-FES PET/CT in Metastatic Breast Cancer

NCT07316439

Sponsor

Fudan University

Status

Active, not recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

197Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2024Actual

Primary Completion Date

Jun 5, 2025Actual

Completion Date

Jun 5, 2026Estimated

First Submitted Date

Dec 19, 2025

First Submission Date that Met QC Criteria

Dec 19, 2025

First Posted Date

Jan 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2025

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

197Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Progression-Free Survival		6 weeks

Measure	Description	Time Frame
Overall Response Rate		6 weeks
Disease Control Rate		6 weeks

Eligibility Module

Eligibility Criteria

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 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center		Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided