NCT07187752

Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes

A Prospective and Multicenter Clinical Study to Identify the Molecular Characterization and Subtypes in Patients With HER2-positive Breast Cancer Receiving Neoadjuvant Trastuzumab and Pertuzumab.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,039 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks)
DRUG	Pertuzumab	Pertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks)
DRUG	Chemotherapy	Chemotherapy chosen by the investigators.
PROCEDURE	Excision of tumor/mastectomy	Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-09-23
• Last updated: 2025-09-23