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

NCT ID: NCT05802225

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2026-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BCD-178 group

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

Group Type: EXPERIMENTAL

BCD-178

Intervention Type: DRUG

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

Perjeta Group

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

Group Type: ACTIVE_COMPARATOR

Perjeta

Intervention Type: DRUG

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

Interventions

BCD-178

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

Intervention Type: DRUG

Perjeta

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

Intervention Type: DRUG

Other Intervention Names

pertuzumab; pertuzumab

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Russia

Other Identifiers

BCD-178-2

Identifier Type: -

Identifier Source: org_study_id