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

NCT05802225 | Active Not Recruiting Phase 3

• 1 other identifier: BCD-178-2
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate

  Proportion of subjects achieving tpCR

  immediately after the surgery

Secondary Outcomes (6)

• breast pathological complete response (bpCR) rate

  immediately after the surgery

• overall response rate (ORR)

  at Week 18

• breast-conserving surgery rate

  immediately after surgery

• safety assessment

  up to 65 weeks

• immunogenicity assessment

  pre-dose to week 52, 5 timepoints

Study Arms (2)

BCD-178 group

EXPERIMENTAL

Neoadjuvant therapy stage (6 cycles, 18 weeks): BCD-178, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab

Drug: BCD-178

Perjeta Group

ACTIVE COMPARATOR

Neoadjuvant therapy stage (6 cycles, 18 weeks): Perjeta, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab

Drug: Perjeta

Interventions

BCD-178 DRUG

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

Also known as: pertuzumab

BCD-178 group

Perjeta DRUG

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

Also known as: pertuzumab

Perjeta Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent ;
• Histologically confirmed diagnosis of invasive breast cancer;
• Disease stage cT2-cT4, cN0-cN3, cM0;
• Positive HER2 expression, negative estrogen and progesterone receptor expression;
• ECOG score 0-1;
• Adequate organ function;
• Baseline LVEF ≥ 55%, as measured with the standard procedure;
• Consent of women of childbearing potential to use highly effective methods of contraception, starting from the signing of the informed consent form, throughout the study and for 6 months after receiving the last dose of the product.

You may not qualify if:

• Stage IV (metastatic) breast cancer;
• A history of any systemic therapy for breast cancer;
• Concomitant diseases and/or conditions that significantly increase the risk of adverse events during the study;
• Pregnancy or breastfeeding, as well as pregnancy planning throughout the study and for 6 months after receiving the last dose of the product;
• Hypersensitivity or allergy to any of the components of BCD-178, Perjeta, trastuzumab, carboplatin, and docetaxel.

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

JSC "Modern Medical Technologies"

Saint Petersburg, Sankt-Peterburg, 190013, Russia

Location

The Loginov Moscow Clinical Scientific Center MHD

Moscow, 111123, Russia

Location

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

Omsk, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 6, 2023
• Study Start: January 30, 2023
• Primary Completion: June 6, 2025
• Study Completion: February 20, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)