NCT07057427

Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 812 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nab paclitaxel	Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)
DRUG	Docetaxel and Carboplatin	Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)
DRUG	Trastuzumab + Pertuzumab	Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

Timeline

• Start date: 2025-06-24
• Primary completion: 2028-06-30
• Completion: 2029-06-30
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China