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

Fudan University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06655545

YOUNGBC-31

Details and patient eligibility

About

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

Enrollment: 473 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

473 participants in 4 patient groups

FES-guided CDK4/6 inhibitor plus endocrine therapy cohort

Description:

The group guided with FES-PET using a CDK4/6 inhibitor plus ET.

FES-guided chemotherapy cohort

Description:

The group guided with FES-PET using chemotherapy.

Non-FES-guided CDK4/6 inhibitor plus endocrine therapy cohort

Description:

The group examined without FES-PET using a CDK4/6 inhibitor plus ET.

Non-FES-guided chemotherapy cohort

Description:

The group examined without FES-PET using chemotherapy.