Ignite Creation Date:
2025-12-18 @ 8:16 AM
Ignite Modification Date:
2025-12-18 @ 8:16 AM
Study NCT ID:
NCT01432223
Status:
None
Last Update Posted:
2015-04-22 00:00:00
First Post:
2011-09-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
Status:
None
Status Verified Date:
2015-04
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:
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: