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

PHASE3RecruitingINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

October 30, 2024

Study Completion Date

January 31, 2028

Conditions
Breast Cancer
Interventions
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

Trial Locations (1)

Unknown

RECRUITING

Sunyat-sen Memorial Hospital, Guandong

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

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 | Biotech Hunter | Biotech Hunter