Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04193059
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2019-12-08
Brief Title:
Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel EC-T Verses Paclitaxel Combined With Carboplatin PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
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:
PANSY
Brief Summary:
This study is a randomized single center phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel EC4-T4 verses 6 cycles of weekly paclitaxel combined with carboplatin PCb6 in the adjuvant chemotherapy of non-triple negative breast cancer patients The study is divided in to 2 branches PANSY-1 and PANSY-2 PANSY-1 is a study of hormone receptor HR-positivehuman epidermal growth factor receptor-2 HER2-negative patients with 4 positive lymph node while PANSY-2 is a study of HER2-positive patients with 1 positive lymph node
Detailed Description:
PANSY-1 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel EC-T verses six cycles of paclitaxel combined with carboplatin PCb
PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab EC-TH verses six cycles of paclitaxel combined with carboplatin and trastuzumab PCbH both followed by 1 year adjuvant trastuzumab
After pertuzumab became legally available in China participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab EC-THP verses six cycles of paclitaxel combined with carboplatin trastuzumab and pertuzumab PCbHP both followed by 1 year adjuvant trastuzumab and pertuzumab
With the inclusion of pertuzumab in Chinas medical insurance in January 2020 study protocols were revised to include dual targeted therapy for HER2-positive participants
PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab EC-TH verses six cycles of paclitaxel combined with carboplatin and trastuzumab PCbH both followed by 1 year adjuvant trastuzumab
After pertuzumab became legally available in China participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab EC-THP verses six cycles of paclitaxel combined with carboplatin trastuzumab and pertuzumab PCbHP both followed by 1 year adjuvant trastuzumab and pertuzumab
With the inclusion of pertuzumab in Chinas medical insurance in January 2020 study protocols were revised to include dual targeted therapy for HER2-positive participants
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