18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

• Sponsor: Biyun Wang, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT04756921
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 22.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HER2-positive Breast Cancer	Drug: Pyrotinib

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pretreatment 18F-FDG Uptake Heterogeneity Predicts Response to Pyrotinib in Patients With Metastatic HER2-positive Breast Cancer
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Jul 24, 2020
• Actual Study Completion Date: Jul 24, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. PFS [Through study completion, an expected average of 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Biyun Wang, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biyun Wang, MD, Clinical Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT04756921
• Other Study ID Numbers: YOUNGBC-13
• First Posted: Feb 16, 2021
• Last Update Posted: Feb 16, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 16, 2021