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Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517305
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Biyun Wang, MD, Fudan University

Study Description
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Brief Summary:
To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pyrotinib Plus Vinorelbine in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 6 weeks ]
    Progression free survival

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517305


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Biyun Wang, Professor Fudan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biyun Wang, MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04517305    
Other Study ID Numbers: YOUNGBC-10
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biyun Wang, MD, Fudan University:
Pyrotinib
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases