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

A Double-Blind, Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: BCD-178; Drug: Perjeta

• Study Type: Interventional
• Enrollment (Estimated): 374
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vladimir Chistiakov; Phone Number: +7 (812) 380 49 34; Email: chistiakov@biocad.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Recruiting
    • The Loginov Moscow Clinical Scientific Center MHD
    • Contact: Lyudmila Zhukova, DMSc
  • Omsk, Russian Federation
    • Recruiting
    • Budgetary healthcare institution of the Omsk region "Clinical Oncological Dispensary"
    • Contact: Anastasiia V Zimina; Phone Number: +7 (3812) 60 16 95; Email: omonkol_mail@minzdrav.omskportal.ru
  • Saint Petersburg, Russian Federation, 190013
    • Recruiting
    • JSC "Modern Medical Technologies"
    • Contact: Svetlana V Odintsova, MD; Phone Number: +7-(812)-380-49-34; Email: odin-svet@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: BCD-178; at an initial dose of 840 mg (1 cycle), then 420 mg; Other Names: pertuzumab
Active Comparator: 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	Drug: Perjeta; at an initial dose of 840 mg (1 cycle), then 420 mg; Other Names: pertuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
breast pathological complete response (bpCR) rate	Proportion of subjects achieving bpCR;	immediately after the surgery
overall response rate (ORR)	the ORR according to RECIST 1.1 criteria	at Week 18
breast-conserving surgery rate	Proportion of subjects with breast-conserving surgery	immediately after surgery
safety assessment	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	up to 65 weeks
immunogenicity assessment	Proportion of subjects with binding and neutralizing antibodies	pre-dose to week 52, 5 timepoints
Pharmacokinetics assessment	Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion	pre-dose to week 18, 12 timepoints

Collaborators and Investigators

• Sponsor: Biocad

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): January 22, 2024
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: BCD-178-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No