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Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer

NCT04957212 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-07-26

Study results available
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Summary

This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast cancer patients.

Patients were stratified dynamically for random assignment to treatment with either Pertuzumab® (CinnaGen Co.) or originator pertuzumab, and received neoadjuvant TCHP regimen every 3- weeks.

Conditions

Interventions

DRUG

Trastuzumab

An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks

DRUG

Pertuzumab

An initial dose of 840 mg, followed by 420 mg every 3-weeks

DRUG

Carboplatin

A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks

DRUG

Docetaxel

75 mg/m2 every 3-weeks

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Behrouz Najafi, MD · Assistant Professor of Hematology and Oncology Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-11
Primary Completion
2020-05-27
Completion
2020-05-27

Countries

  • Iran

Study Locations

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Entities

Drugs
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 NCT04957212 on ClinicalTrials.gov