Breast Cancer
Conditions
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.
Interventions
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| breast pathological complete response (bpCR) rate | immediately after the surgery | Proportion of subjects achieving bpCR; |
| 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 |
| 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 |
Countries
Russia
Outcome results
None listed