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Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

NCT06144944 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-30

No results posted yet for this study

Summary

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer

Conditions

Interventions

DRUG

Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Pyrotinib 320 mg orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

DRUG

Epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Chang Gong, Prof · Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2026-06-30
Completion
2031-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT06144944 on ClinicalTrials.gov