NCT04517305

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 15, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

August 16, 2020

Last Update Submit

June 17, 2021

Conditions

Breast Cancer

Keywords

Pyrotinib

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression free survival

    6 weeks

  • Adverse events

    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

Study Arms (1)

Pyrotinib plus vinorelbine

Patients used pyrotinib plus vinorelbine as treatment for metastatic breast cancer.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • medical history was incomplete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Li Y, Qiu Y, Li H, Luo T, Li W, Wang H, Shao B, Wang B, Ge R. Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study. Front Oncol. 2021 Apr 20;11:664429. doi: 10.3389/fonc.2021.664429. eCollection 2021.

    PMID: 33996589DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

May 15, 2018

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

CN(1)