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Completed

NCT Number: NCT04992156

Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET

To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18-70 years.
  • Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
  • HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
  • Palbociclib treatment of metastatic breast cancer for at least one cycle.
  • Available medical history.

Exclusion criteria

1.Incomplete medical history.

Treatment and study plan

Palbociclib

Drug

Palbociclib 125mg/d

Primary outcomes

  1. PFS

    Time frame: Through study completion, an expected average of 12 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
May 19, 2022

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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