Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

April 20, 2023 updated by: Biyun Wang, MD, Fudan University

Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

161

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
  • received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09
  • 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

Cohorts and Interventions

Group / Cohort
PyroHC
Patients used pyrotinib (Pyro) plus trastuzumab (H) and chemotherapy (C) as treatment for metastatic breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 6 weeks
Progression free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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)

November 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-26

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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