Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
- Registration Number
- NCT05802225
- Lead Sponsor
- Biocad
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 374
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCD-178 group BCD-178 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 Perjeta Group Perjeta 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
- Primary Outcome Measures
Name Time Method To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate immediately after the surgery Proportion of subjects achieving tpCR
- Secondary Outcome Measures
Name Time Method breast pathological complete response (bpCR) rate immediately after the surgery Proportion of subjects achieving bpCR;
overall response rate (ORR) at Week 18 the ORR according to RECIST 1.1 criteria
breast-conserving surgery rate immediately after surgery Proportion of subjects with breast-conserving surgery
safety assessment 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
immunogenicity assessment pre-dose to week 52, 5 timepoints Proportion of subjects with binding and neutralizing antibodies
Pharmacokinetics assessment pre-dose to week 18, 12 timepoints Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion
Trial Locations
- Locations (3)
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
🇷🇺Omsk, Russian Federation
The Loginov Moscow Clinical Scientific Center MHD
🇷🇺Moscow, Russian Federation
JSC "Modern Medical Technologies"
🇷🇺Saint Petersburg, Russian Federation