18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Tr... | NCT06655545

Studies
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients

NCT06655545

Sponsor

Fudan University

Status

Completed

Last Update Posted

May 7, 2025Actual

Enrollment

473Actual

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 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2023Actual

Primary Completion Date

Oct 15, 2024Actual

Completion Date

Feb 1, 2025Actual

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

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

May 6, 2025

Last Update Posted Date

May 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.

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

473Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FES-guided CDK4/6 inhibitor plus endocrine therapy cohort		The group guided with FES-PET using a CDK4/6 inhibitor plus ET.
FES-guided chemotherapy cohort		The group guided with FES-PET using chemotherapy.
Non-FES-guided CDK4/6 inhibitor plus endocrine therapy cohort		The group examined without FES-PET using a CDK4/6 inhibitor plus ET.
Non-FES-guided chemotherapy cohort		The group examined without FES-PET using chemotherapy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	progression-free survival	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
OS	overall-survival	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >= 18 years old;
Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024;
Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.

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

Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Biyun Wang, professor	Fudan University	Principal Investigator

Locations

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

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