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OpenTrials
Completed

NCT Number: NCT06655545

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Medical history was incomplete.

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    progression-free survival

Secondary outcomes

  1. OS

    Time frame: 6 weeks

    overall-survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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