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Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

NCT07797218 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-09-01

No results posted yet for this study

Summary

This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.

Conditions

  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

DRUG

Docetaxel

docetaxel ivgtt q3w, 80-100mg/m2

DRUG

Pyrotinib

pyrotinib 320mg p.o. qd

DRUG

Trastuzumab (Herceptin)

trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w

DRUG

Pertuzumab

pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

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
2026-07-01
Primary Completion
2028-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT07797218 on ClinicalTrials.gov