Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03881878
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-03-11
Brief Title:
TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant tHerapy After Surgery
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Docetaxel Plus Atezolizumab Plus Herceptin SC and Pertuzumab TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent Atezolizumab Plus Herceptin SC and Pertuzumab AHP Adjuvant tHerapy After Surgery
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
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 study was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel atezolizumab Herceptin sc plus pertuzumabTAHP plus adjuvant therapy of atezolizumab trastuzumab pertuzumabAHP after surgery in female patients with HER2-positive early breast cancer
Adjuvant AHP atezolizumab Herceptin SC pertuzumab will be continued for remaining 1 year
For non-p CR patients they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy
Adjuvant AHP atezolizumab Herceptin SC pertuzumab will be continued for remaining 1 year
For non-p CR patients they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy
Detailed Description:
A Neoadjuvant setting 6 cycles q3weeks intravenousIV administration
Docetaxel 75mgm2 intravenousIV DayD1
Atezolizumab 1200mg IV D1
Herceptin sc 600mg subcutaneousSCD1
Pertuzumab 840mg loading dose at Cycle 1 followed by 420mgIVD1
B Adjuvant setting 11-12 cycles q3weeks patients with pCR
Atezolizumab 1200mg IV
Trastuzumab 600mg SC
Pertuzumab 420mg IV D1
patients with non-pCR
Doxorubicin60mgm2 cyclophosphamide 600mgm2 D1 X 4cycles 3weeks
Atezolizumab 1200mg IV
Trastuzumab 600mg SC
Pertuzumab 420mg IV D1 X 11-12 cycles q3weeks
Docetaxel 75mgm2 intravenousIV DayD1
Atezolizumab 1200mg IV D1
Herceptin sc 600mg subcutaneousSCD1
Pertuzumab 840mg loading dose at Cycle 1 followed by 420mgIVD1
B Adjuvant setting 11-12 cycles q3weeks patients with pCR
Atezolizumab 1200mg IV
Trastuzumab 600mg SC
Pertuzumab 420mg IV D1
patients with non-pCR
Doxorubicin60mgm2 cyclophosphamide 600mgm2 D1 X 4cycles 3weeks
Atezolizumab 1200mg IV
Trastuzumab 600mg SC
Pertuzumab 420mg IV D1 X 11-12 cycles q3weeks
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