NCT04756921

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

February 5, 2021

Last Update Submit

February 12, 2021

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Through study completion, an expected average of 12 months

Study Arms (1)

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

Interventions

PyrotinibDRUG

Pyrotinib 400mg po qd

Patients cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete medical history
  • Loss of follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

pyrotinib

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 16, 2021

Study Start

September 1, 2018

Primary Completion

July 24, 2020

Study Completion

July 24, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

CN(1)