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

Biocad

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Drug: BCD-178; Drug: Perjeta

Study type: Interventional

Funder types: Industry

Identifiers

NCT05802225

BCD-178-2

Details and patient eligibility

About

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.

Enrollment: 374 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 2 patient groups

BCD-178 group

Experimental group

Description:

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

Treatment:

Drug: BCD-178

Perjeta Group

Active Comparator group

Description:

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

Treatment:

Drug: Perjeta