Back to resultsClinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer (PREFER)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
BCD-178
Perjeta
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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.
Sites / Locations
- The Loginov Moscow Clinical Scientific Center MHDRecruiting
- Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"Recruiting
- JSC "Modern Medical Technologies"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BCD-178 group
Perjeta Group
Arm 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
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
Outcomes
Primary Outcome Measures
To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate
Proportion of subjects achieving tpCR
Secondary Outcome Measures
breast pathological complete response (bpCR) rate
Proportion of subjects achieving bpCR;
overall response rate (ORR)
the ORR according to RECIST 1.1 criteria
breast-conserving surgery rate
Proportion of subjects with breast-conserving surgery
safety assessment
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
Proportion of subjects with binding and neutralizing antibodies
Pharmacokinetics assessment
Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05802225
Brief Title
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
Acronym
PREFER
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
January 22, 2024 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BCD-178 group
Arm Type
Experimental
Arm 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
Arm Title
Perjeta Group
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
BCD-178
Other Intervention Name(s)
pertuzumab
Intervention Description
at an initial dose of 840 mg (1 cycle), then 420 mg
Intervention Type
Drug
Intervention Name(s)
Perjeta
Other Intervention Name(s)
pertuzumab
Intervention Description
at an initial dose of 840 mg (1 cycle), then 420 mg
Primary Outcome Measure Information:
Title
To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate
Description
Proportion of subjects achieving tpCR
Time Frame
immediately after the surgery
Secondary Outcome Measure Information:
Title
breast pathological complete response (bpCR) rate
Description
Proportion of subjects achieving bpCR;
Time Frame
immediately after the surgery
Title
overall response rate (ORR)
Description
the ORR according to RECIST 1.1 criteria
Time Frame
at Week 18
Title
breast-conserving surgery rate
Description
Proportion of subjects with breast-conserving surgery
Time Frame
immediately after surgery
Title
safety assessment
Description
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
Time Frame
up to 65 weeks
Title
immunogenicity assessment
Description
Proportion of subjects with binding and neutralizing antibodies
Time Frame
pre-dose to week 52, 5 timepoints
Title
Pharmacokinetics assessment
Description
Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion
Time Frame
pre-dose to week 18, 12 timepoints
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Chistiakov
Phone
+7 (812) 380 49 34
Email
chistiakov@biocad.ru
Facility Information:
Facility Name
The Loginov Moscow Clinical Scientific Center MHD
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyudmila Zhukova, DMSc
Facility Name
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
City
Omsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasiia V Zimina
Phone
+7 (3812) 60 16 95
Email
omonkol_mail@minzdrav.omskportal.ru
Facility Name
JSC "Modern Medical Technologies"
City
Saint Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana V Odintsova, MD
Phone
+7-(812)-380-49-34
Email
odin-svet@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
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