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Trial Title:
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
NCT ID:
NCT05802225
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Pertuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
BCD-178
Description:
at an initial dose of 840 mg (1 cycle), then 420 mg
Arm group label:
BCD-178 group
Other name:
pertuzumab
Intervention type:
Drug
Intervention name:
Perjeta
Description:
at an initial dose of 840 mg (1 cycle), then 420 mg
Arm group label:
Perjeta Group
Other name:
pertuzumab
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Loginov Moscow Clinical Scientific Center MHD
Address:
City:
Moscow
Zip:
111123
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Lyudmila Zhukova, DMSc
Facility:
Name:
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasiia V Zimina
Phone:
+7 (3812) 60 16 95
Email:
omonkol_mail@minzdrav.omskportal.ru
Facility:
Name:
JSC "Modern Medical Technologies"
Address:
City:
Saint Petersburg
Zip:
190013
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Svetlana V Odintsova, MD
Phone:
+7-(812)-380-49-34
Email:
odin-svet@yandex.ru
Start date:
January 30, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802225
