Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

NCT ID: NCT04850625

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-06-15

Brief Summary

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Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Detailed Description

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This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pyrotinib Plus Vinorelbine

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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Incomplete medical history
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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YOUNGBC-14

Identifier Type: -

Identifier Source: org_study_id

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