NCT04850625

Brief Summary

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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

January 15, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

April 16, 2021

Last Update Submit

June 30, 2022

Conditions

Breast Cancer

Keywords

PyrotinibLapatinibVinorelbine

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 weeks

Study Arms (2)

Pyrotinib Plus Vinorelbine

lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2)

Lapatinib Plus Capecitabine

pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days)

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 ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

You may qualify if:

  • HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
  • Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
  • Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021.
  • Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

You may not qualify if:

  • Incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

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

April 16, 2021

First Posted

April 20, 2021

Study Start

January 15, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

CN(1)