Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05346224
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2022-04-17
Brief Title:
A Study to Evaluate the Efficacy and Safety of HLX11 vs EU-Perjeta in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs EU-Perjeta in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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 pertuzumab biosimilar HLX11 vs EU-Perjeta on HER2-positive and HR-negative early-stage or locally advanced breast cancer with a primary tumor 2 cm
Patients are random assignment to 2 arms and treatment with either HLX11 or EU-Perjeta and received neoadjuvant THP regimen every 3- weeks 4 cyclesadjuvant AC every 3- weeks 4 cycles and pertuzumabtrastuzumabHP every 3- weeks 13cycles
Patients are random assignment to 2 arms and treatment with either HLX11 or EU-Perjeta and received neoadjuvant THP regimen every 3- weeks 4 cyclesadjuvant AC every 3- weeks 4 cycles and pertuzumabtrastuzumabHP every 3- weeks 13cycles
Detailed Description:
This is a phase III double-blind randomized parallel-controlled multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs EU-Perjeta on HER2-positive and HR-negative early-stage or locally advanced breast cancer with a primary tumor 2 cmSubjects will be randomly assigned to treatment group HLX11 or control group EU-Perjeta at 11 ratio The stratification factors include disease category early-stage vs locally advanced and geographic region Asia vs non-Asia
Study drugs will be administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence trastuzumab followed by pertuzumab and docetaxelTHP regimen for neoadjuvantDoxorubicin in combination with cyclophosphamide AC for adjuvant chemotherapy then HP regimen for adjuvant HER2-targeted
The primary endpoint is total pCR tpCR Secondary efficacy endpoints include breast pCR bpCR objective response rate ORREvent-free survival EFS and Disease-free survival DFS
The safety indicators is incidence type severity and causality of all adverse events including serious adverse events and AESI based on NCI CTCAE v50 Vital signs physical examination laboratory tests cardiac function test etc
pharmacokineticPK and immunogenicity is also assessed
Study drugs will be administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence trastuzumab followed by pertuzumab and docetaxelTHP regimen for neoadjuvantDoxorubicin in combination with cyclophosphamide AC for adjuvant chemotherapy then HP regimen for adjuvant HER2-targeted
The primary endpoint is total pCR tpCR Secondary efficacy endpoints include breast pCR bpCR objective response rate ORREvent-free survival EFS and Disease-free survival DFS
The safety indicators is incidence type severity and causality of all adverse events including serious adverse events and AESI based on NCI CTCAE v50 Vital signs physical examination laboratory tests cardiac function test etc
pharmacokineticPK and immunogenicity is also assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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