Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04172259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-16
First Post:
2018-12-18
Brief Title:
ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Multi-center Randomized Phase II Study of Doxorubicin Liposome Versus Epirubicin Plus Cyclophosphamide Combined With Trastuzumab and PertuzumabHP Followed by Taxon Plus HP as Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
Breast cancer is the most common malignant tumor in women EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancerEBC Earlier use of trastuzumab may improve DFS rate In this study the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2 EBC could improve the pCR rate in neoadjuvant chemotherapy
We update protocol in Sep 2020 because Pertuzumab is approveled by Chinese goverment and coverd by national insurance dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients
We update protocol in Sep 2020 because Pertuzumab is approveled by Chinese goverment and coverd by national insurance dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients
Detailed Description:
Breast cancer is the most common malignant tumor in women EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancerEBC Earlier use of trastuzumab could improve the DFS rate in HER2 EBC But due to the cardio-toxicity of both anthracycline and trastuzumab the investigators usually avoid using these two drugs synchronously The guidelines do not recommend ECH-TH regemin because of cardiac adverse effect Doxorubicin liposomeA has equivalent effect as anthracycline in advaced breast cancerABC lower cardiac toxicity and could be combined use with trastuzumab In this study the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2 EBC could improve the pCR rate in neoadjuvant chemotherapy
We update protocol in Sep 2020 because Pertuzumab is approveled by Chinese goverment and coverd by national insurance dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients So now we want to compare ACHP-THP regimen compared with the EC-THP regimen in HER2 EBC could improve the pCR rate in neoadjuvant chemotherapy
We update protocol in Sep 2020 because Pertuzumab is approveled by Chinese goverment and coverd by national insurance dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients So now we want to compare ACHP-THP regimen compared with the EC-THP regimen in HER2 EBC could improve the pCR rate in neoadjuvant chemotherapy
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCBCG-023 | OTHER | South China Breast Cancer Group | None |