NCT05159193

Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (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 multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin (PLD)	pegylated liposomal doxorubicin (PLD) 30 mg/m\^2, i.v., d1, q3w
DRUG	cyclophosphamide (C)	cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q3w
DRUG	trastuzumab (H)	trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
DRUG	pertuzumab (P)	pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w
DRUG	docetaxel (T)	docetaxel (T) 90\~100 mg/m\^2, i.v., d1, q3w
DRUG	docetaxel (T)	docetaxel (T) 75 mg/m\^2, i.v., d1, q3w
DRUG	carboplatin (Cb)	carboplatin (Cb) AUC 6, i.v., d1, q3w
DRUG	trastuzumab (H)	trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
DRUG	pertuzumab (P)	pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w

Timeline

• Start date: 2021-12-20
• Primary completion: 2024-10-30
• Completion: 2028-01-31
• First posted: 2021-12-16
• Last updated: 2024-02-02

Locations

1 site across 1 country: China