NCT06843681

Trastuzumab Plus Taxane Neoadjuvant Therapy for HER2-Positive Breast Ductal Carcinoma In Situ (DCIS) : A Phase II Study

Trastuzumab Combined With Taxane Neoadjuvant Therapy for HER2-positive Breast Carcinoma in Situ: a Phase II Single-arm Clinical Study

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive carcinoma).

Detailed description

This Phase II single-center, single-arm clinical study was designed to evaluate the efficacy and safety of trastuzumab combined with taxane as a neoadjuvant treatment for patients with HER2-positive breast cancer in situ or invasive breast cancer. The study was designed to determine breast-conserving surgery rates and pathologic complete response (pCR) rates, assess tumor size reduction, and evaluate potential adverse events associated with treatment options. Participants will be treated with trastuzumab and taxane on a prescribed schedule, with periodic evaluations including imaging, histopathological analysis, and safety monitoring. The aim is to gain insight into the therapeutic potential of this combination therapy in improving outcomes for patients with HER2-positive breast cancer.

Conditions

• Breast Carcinoma in Situ

Interventions

Type	Name	Description
DRUG	Trastuzumab combined with taxane neoadjuvant therapy	Trastuzumab combined with taxane neoadjuvant therapy

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-01-01
• Completion: 2030-01-01
• First posted: 2025-02-25
• Last updated: 2025-11-28

Locations

1 site across 1 country: China