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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

NCT05159193 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2024-02-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2024-10-30
Completion
2028-01-31

Countries

  • China

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159193 on ClinicalTrials.gov