18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

Completed

• Conditions: HER2-positive Breast Cancer
• Interventions: Drug: Pyrotinib

• Registration Number: NCT04756921
• Lead Sponsor: Biyun Wang, MD

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients cohort	Pyrotinib	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.

Primary Outcome Measures

Name	Time	Method
PFS	Through study completion, an expected average of 12 months

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China