Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136539
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2005-08-26
Brief Title:
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Sponsor:
Harold J Burstein MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Neoadjuvant Therapy With Herceptin and Taxol for Stage IIIII Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 determine the effectiveness and safety of administering Herceptin in combination with Taxol paclitaxel in the treatment of women with HER2-positive early stage breast cancer prior to surgery
Detailed Description:
Patients will receive Herceptin intravenously once weekly for 12 weeks and Taxol intravenously every 3 weeks week 1 week 4 week 7 and week 10
After 12 weeks of treatment breast surgery will be performed either a lumpectomy or a mastectomy
Once patients have recovered from the surgery they will receive adriamycin and cytoxan every 3 weeks for 4 cycles 12 weeks total
After Herceptin and Taxol therapy tumor assessment will be performed along with an echocardiogram and mammogram
At the time of surgery re-assessment of the tumor will be done
Blood work will be performed on day one of each chemotherapy cycle
After 12 weeks of treatment breast surgery will be performed either a lumpectomy or a mastectomy
Once patients have recovered from the surgery they will receive adriamycin and cytoxan every 3 weeks for 4 cycles 12 weeks total
After Herceptin and Taxol therapy tumor assessment will be performed along with an echocardiogram and mammogram
At the time of surgery re-assessment of the tumor will be done
Blood work will be performed on day one of each chemotherapy cycle
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