NCT06655545

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
473

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 7, 2025

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

October 22, 2024

Last Update Submit

May 6, 2025

Conditions

Breast Cancer

Keywords

chemotherapyCDK4/6 inhibitors18F-fluoroestradiol (18F-FES) PET/CTHR positiveHER2 negative

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression-free survival

    6 weeks

Secondary Outcomes (1)

  • OS

    6 weeks

Study Arms (4)

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.

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • \. Medical history was incomplete.

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 Officials

  • Biyun Wang, professor

    Fudan University

    PRINCIPAL INVESTIGATOR

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

October 22, 2024

First Posted

October 23, 2024

Study Start

July 15, 2023

Primary Completion

October 15, 2024

Study Completion

February 1, 2025

Last Updated

May 7, 2025

Record last verified: 2024-12

Locations

CN(1)