Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802225
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-02-13
Brief Title:
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta as Neoadjuvant Therapy of HER2-Positive Breast Cancer
Sponsor:
Biocad
Organization:
Biocad
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFER
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 11 ratio
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 11 ratio
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None