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

A Single-center, Real-world Study Exploring the Guidance of FES-PET for First-line Treatment of HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06655545

Enrollment

473

Registered

2024-10-23

Start date

2023-07-15

Completion date

2025-02-01

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

chemotherapy, CDK4/6 inhibitors, 18F-fluoroestradiol (18F-FES) PET/CT, HR positive, HER2 negative

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. age \>= 18 years old; 2. 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; 3. Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle; 4. Complete medical history was available.

Exclusion criteria

1\. Medical history was incomplete.

Design outcomes

Primary

Measure	Time frame	Description
PFS	6 weeks	progression-free survival

Secondary

Measure	Time frame	Description
OS	6 weeks	overall-survival

Countries

China

Outcome results