Clinical trial NCT05802225: Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate
timeFrame: immediately after the surgery
Secondary outcomes:
measure: breast pathological complete response (bpCR) rate
timeFrame: immediately after the surgery
measure: overall response rate (ORR)
timeFrame: at Week 18
measure: breast-conserving surgery rate
timeFrame: immediately after surgery
measure: safety assessment
timeFrame: up to 65 weeks
measure: immunogenicity assessment
timeFrame: pre-dose to week 52, 5 timepoints
measure: Pharmacokinetics assessment
timeFrame: pre-dose to week 18, 12 timepoints
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The Loginov Moscow Clinical Scientific Center MHD
city: Omsk
country: Russian Federation
facility: Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
city: Saint Petersburg
country: Russian Federation
facility: JSC "Modern Medical Technologies"
Study officials:
References: