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ACTIVE NOT RECRUITING
NCT05802225
PHASE3

Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

Sponsor: Biocad

View on ClinicalTrials.gov

Summary

The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer. Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size \> 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio.

Official title: A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

398

Start Date

2023-01-30

Completion Date

2026-02-20

Last Updated

2025-07-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

BCD-178

at an initial dose of 840 mg (1 cycle), then 420 mg

DRUG

Perjeta

at an initial dose of 840 mg (1 cycle), then 420 mg

Locations (3)

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, Russia

The Loginov Moscow Clinical Scientific Center MHD

Moscow, Russia

Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"

Omsk, Russia