Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720026
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2022-11-25
Brief Title:
Study to Evaluate the Efficacy and Safety of SYSA1901 vs Perjeta of HER2-Positive Breast Cancer
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Organization:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab Perjeta in the Neoadjuvant Therapy of HER2-Positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-02
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:
None
Brief Summary:
This is a phase Ⅲ double-blind randomized parallel-controlled multicenter equivalence study to compare the efficacy and safety of SYSA1901 trastuzumab docetaxel vs Perjeta trastuzumab docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor 2 cm
Detailed Description:
This is a phase Ⅲ double-blind randomized parallel-controlled multicenter equivalence study to compare the efficacy and safety of SYSA1901 trastuzumab docetaxel vs Perjeta trastuzumab docetaxel in the patients with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor 2 cm The eligible patients will be randomized to treatment group SYSA1901 Trastuzumab Docetaxel or control group Perjeta Trastuzumab Docetaxel at 11 ratio The stratification factor is disease category early-stage vs locally advanced
The primary endpoint is total pCR tpCR Secondary efficacy endpoints include breast pCR bpCR objective response rate ORRpharmacokinetic PK and immunogenicity
The primary endpoint is total pCR tpCR Secondary efficacy endpoints include breast pCR bpCR objective response rate ORRpharmacokinetic PK and immunogenicity
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