NCT04609540

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 16, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 24, 2020

Last Update Submit

December 14, 2020

Conditions

HER2-positive Breast CancerMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival(PFS)

    The time from starting pyrotinib until disease progression or death from any cause.

    1 year

Secondary Outcomes (3)

  • Overall survival(OS)

    1 year

  • Objective Response Rate(ORR)

    1 year

  • Safety

    1 year

Study Arms (1)

Pyrotinib and Trastuzumab group

Dual anti-HER2 therapy (pyrotinib and trastuzumab) and chemotherapy

Drug: Trastuzumab

Interventions

TrastuzumabDRUG

Dual anti-HER2 therapy

Also known as: Pyrotinib
Pyrotinib and Trastuzumab group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HER2 positive Metastatic Breast Cancer

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumabpyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Zhiyong Yu, PhD

CONTACT

86-13355312277drzhiyongyu@aliyun.com

Chao Li, MD

CONTACT

86-15665851082lichao19890305@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 30, 2020

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

December 16, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share