NCT05802225

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Biocad · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-06-06
• Completion: 2026-02-20
• First posted: 2023-04-06
• Last updated: 2025-07-20

Locations

3 sites across 1 country: Russia