Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients

June 17, 2021 updated by: Biyun Wang, MD, Fudan University

Pyrotinib Plus Vinorelbine in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Description

Inclusion Criteria:

  • woman, age > 18 years old
  • diagnosed with HER2 +Metastatic Breast Cancer
  • pyrotinib plus vinorelbine for at least one cycle, starting from 2018.05-2020.05
  • available medical history

Exclusion Criteria:

  • medical history was incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Pyrotinib plus vinorelbine
Patients used pyrotinib plus vinorelbine as treatment for metastatic breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks
Adverse events
Time Frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 16, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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