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Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04850625
Enrollment
224
Registered
2021-04-20
Start date
2020-01-15
Completion date
2021-06-15
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Pyrotinib, Lapatinib, Vinorelbine

Brief summary

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Detailed description

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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PFS6 weeksProgression free survival

Secondary

MeasureTime frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.06 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026