NCT07047755

Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.

Detailed description

Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Rezetecan	Trastuzumab Rezetecan
DRUG	Pertuzumab	Pertuzumab

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2031-02-28
• First posted: 2025-07-02
• Last updated: 2025-07-02