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Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
Sponsor: Biocad
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
398
Start Date
2023-01-30
Completion Date
2026-02-20
Last Updated
2025-07-20
Healthy Volunteers
No
Conditions
Interventions
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 (3)
JSC "Modern Medical Technologies"
Saint Petersburg, Sankt-Peterburg, Russia
The Loginov Moscow Clinical Scientific Center MHD
Moscow, Russia
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk, Russia