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NCT04756921 Clinical Trial

18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04756921
Other study ID # YOUNGBC-13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date July 24, 2020

Study information
Verified date February 2021
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 24, 2020
Est. primary completion date July 24, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pyrotinib
Pyrotinib 400mg po qd

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Biyun Wang, MD

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Through study completion, an expected average of 12 months
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