Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270894
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2005-12-28
Brief Title:
Neoadjuvant Chemotherapy Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Sponsor:
Accelerated Community Oncology Research Network
Organization:
Accelerated Community Oncology Research Network
Study Overview
Official Title:
Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients
trastuzumab Herceptin
epirubicin Ellence
cyclophosphamide Cytoxan
docetaxel Taxotere
trastuzumab Herceptin
epirubicin Ellence
cyclophosphamide Cytoxan
docetaxel Taxotere
Detailed Description:
This is an investigator-initiated Phase II non-randomized single-arm prospective treatment study The study will consist of neoadjuvant treatment period weeks 1 to 20 surgical evaluation period weeks 20 to 24 and a post-surgicalfollow-up period approximately 3 years Subjects will be treated on an outpatient basis
Neoadjuvant therapy will consist of epirubicin cyclophosphamide given every 2 weeks for four cycles followed by a three week break Subjects will then receive docetaxel every two weeks for four cycles trastuzumab one loading dose then maintenance dose every 2 weeks for 4 treatments
Neoadjuvant therapy will consist of epirubicin cyclophosphamide given every 2 weeks for four cycles followed by a three week break Subjects will then receive docetaxel every two weeks for four cycles trastuzumab one loading dose then maintenance dose every 2 weeks for 4 treatments
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?:
None