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Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NCT04254263 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2025-09-11

No results posted yet for this study

Summary

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.

Conditions

  • Locally Advanced Breast Cancer

Interventions

DRUG

pyrotinib

pyrotinib 400 mg, orally once daily for one year

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jinsong Lu · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04254263 on ClinicalTrials.gov