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NCT Number: NCT05802225

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

JSC "Modern Medical Technologies", Saint Petersburg, Sankt-Peterburg, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCD-178

Drug

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

Other names: pertuzumab

Perjeta

Drug

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

Other names: pertuzumab

Primary outcomes

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

    Time frame: immediately after the surgery

    Proportion of subjects achieving tpCR

Secondary outcomes

  1. breast pathological complete response (bpCR) rate

    Time frame: immediately after the surgery

    Proportion of subjects achieving bpCR;

  2. overall response rate (ORR)

    Time frame: at Week 18

    the ORR according to RECIST 1.1 criteria

  3. breast-conserving surgery rate

    Time frame: immediately after surgery

    Proportion of subjects with breast-conserving surgery

  4. safety assessment

    Time frame: up to 65 weeks

    Proportion of subjects with adverse reactions; Proportion of subjects with CTCAE 5.0 grade 3 or higher adverse reactions; • Proportion of subjects with serious adverse reactions; • Proportion of subjects who prematurely discontinued neoadjuvant therapy due to adverse reactions

  5. immunogenicity assessment

    Time frame: pre-dose to week 52, 5 timepoints

    Proportion of subjects with binding and neutralizing antibodies

  6. Pharmacokinetics assessment

    Time frame: pre-dose to week 18, 12 timepoints

    Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study 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

Acronym: PREFER

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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