18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

NCT ID: NCT04756921

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-07-24

Brief Summary

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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

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Conditions

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HER2-positive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Pyrotinib

Intervention Type DRUG

Pyrotinib 400mg po qd

Interventions

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Pyrotinib

Pyrotinib 400mg po qd

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Biyun Wang, MD

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YOUNGBC-13

Identifier Type: -

Identifier Source: org_study_id

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