18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

February 12, 2021 updated by: Biyun Wang, MD

Pretreatment 18F-FDG Uptake Heterogeneity Predicts Response to Pyrotinib in Patients With Metastatic HER2-positive Breast Cancer

Heterogeneity of 18F-fluorodeoxyglucose (FDG) uptake is a promising marker for predicting response to treatment. This study aimed to evaluate the ability of pretreatment positron emission tomography/computed tomography (PET/CT) 18F-FDG-based heterogeneity to predict the response to pyrotinib in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with HER2 positive breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Description

Inclusion Criteria:

  • Pathologically confirmed HER2 positive breast cancer
  • Treated with Pyrotinib in the metastatic settings
  • Underwent whole-body FDG PET/CT within 4 weeks before the initiation of pyrotinib and capecitabine were included in this study

Exclusion Criteria:

  • Incomplete medical history
  • Loss of follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients cohort
Patients with HER2 positive MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FDG PET/CT before the initiation of pyrotinib was included.
Drug: Pyrotinib
Pyrotinib 400mg po qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: Through study completion, an expected average of 12 months
Through study completion, an expected average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biyun Wang, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

July 24, 2020

Study Completion (Actual)

July 24, 2020

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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