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

Breast Cancer Clinical Trial

— PREFER  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802225
• Other study ID #: BCD-178-2
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2023
• Source: Biocad
• Contact: Vladimir Chistiakov
• Phone: +7 (812) 380 49 34
• Email: chistiakov[@]biocad.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: January 31, 2026
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• BCD-178
at an initial dose of 840 mg (1 cycle), then 420 mg
• Perjeta
at an initial dose of 840 mg (1 cycle), then 420 mg

Locations

Country	Name	City	State
Russian Federation	The Loginov Moscow Clinical Scientific Center MHD	Moscow
Russian Federation	Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"	Omsk
Russian Federation	JSC "Modern Medical Technologies"	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

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