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Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

NCT04290793 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-01-07

No results posted yet for this study

Summary

This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

Conditions

Interventions

DRUG

Taxanes

Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )

BIOLOGICAL

Trastuzumab

the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W

DRUG

Pyrotinib

400mg administered as continuous oral once daily from the first day of the study

DRUG

Epirubicin

90mg/m\^2 d1 iv Q2W for 4 cycles

DRUG

Cyclophosphamide

600 mg/m\^2 d1 iv Q2W for 4 cycles

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2026-12-01
Completion
2026-12-10

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04290793 on ClinicalTrials.gov