NCT04547907

A Comparison of Nab-PHP and TCbHP Efficacy 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: 688 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Detailed description

In order to compare the effects of nab-PHP and TCbHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen： the neoadjuvant chemotherapy with 6\*nab-PHP regimen group (experimental group): nab-paclitaxel 125mg/m2 on days 1, 8, and 15 every 21 days as one cycle; 6\*TCbHP regimen (control group): docetaxel 75 mg/m2 + carboplatin (AUC=6) on day 1. Both groups will receive trastuzumab (loading dose 8 mg/kg followed by a maintenance dose of 6 mg/kg) on day 1 and pertuzumab (loading dose 840 mg followed by a maintenance dose of 420 mg) on day 1, every 21 days as one cycle. Surgery will be performed after completion of neoadjuvant chemotherapy, with intraoperative excision of specimens (breast + axilla) for pathological evaluation. Comparative analysis of pCR, EFS, iDFS and safety outcomes between the two groups will be conducted using appropriate statistical methods. Safety evaluation will include the incidence of adverse events, incidence of serious adverse events, dose adjustment rate, and discontinuation rate.

Conditions

• Breast Cancer,HER2-positive

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel+ trastuzumab+ patuzumab	Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
DRUG	Docetaxel+ carboplatin+ trastuzumab + patuzumab	Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

Timeline

• Start date: 2020-09-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-09-14
• Last updated: 2024-09-20

Locations

1 site across 1 country: China