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Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer

NCT07340398 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-21

No results posted yet for this study

Summary

This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.

Conditions

  • HER2-positive Early Breast Cancer

Interventions

DRUG

Nab paclitaxel

Nab paclitaxel

DRUG

Carboplatin

carboplatin

DRUG

Trastuzumab

trastuzumab

DRUG

Pertuzumab

pertuzumab

DRUG

SHR-A1811

a HER2-targeted antibody-drug conjugate (ADC)

DRUG

Pyrotinib

Pyrotinib: an oral irreversible pan-HER tyrosine kinase inhibitor (TKI).

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2028-12-31
Completion
2031-01-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07340398 on ClinicalTrials.gov