Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC

December 14, 2020 updated by: Zhiyong Yu, Shandong Cancer Hospital and Institute

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

To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HER2 positive Metastatic Breast Cancer

Description

Inclusion Criteria:

  • woman, age > 18 years old
  • Diagnosed with HER2 +Metastatic Breast Cancer
  • Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31
  • Available medical history

Exclusion Criteria:

  • Incomplete medical history

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
Intervention / Treatment
Pyrotinib and Trastuzumab group
Dual anti-HER2 therapy (pyrotinib and trastuzumab) and chemotherapy
Drug: Trastuzumab
Dual anti-HER2 therapy
Other Names:
  • Pyrotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS)
Time Frame: 1 year
The time from starting pyrotinib until disease progression or death from any cause.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 1 year
The time from starting pyrotinib until death, regardless of cause.
1 year
Objective Response Rate(ORR)
Time Frame: 1 year
The proportion of patients with complete response (CR) or partial response (PR)
1 year
Safety
Time Frame: 1 year
Number of participants with adverse events which were collected at 6 and 18 months after the start of pyrotinib
1 year

Collaborators and Investigators

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

Sponsor

Shandong Cancer Hospital and Institute

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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 24, 2020

First Submitted That Met QC Criteria

October 24, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShandongCHI-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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