Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148681
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2005-09-07
Brief Title:
Preoperative Herceptin and Navelbine for Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Preoperative Herceptin and Navelbine in Early Stage HER-2 Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
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 find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer
Detailed Description:
As part of the patients pre-treatment evaluation a clip will be placed within the tumor bed so that the surgeon can find it at the time of surgery Four biopsies of the tumor will be obtained at the time of the clip placement for further testing at a later date
Depending upon the patients risk level as assessed by the treating physician they will be treated similarly to one of two regimens The first 8 months of both regimens are the same consisting of 12 weeks of herceptin and navelbine followed by surgery and then 4 cycles of adriamycin and cytoxan The treatment following these 8 months will depend upon the health risk to the patient and will be determined by both the patient and treating physician
Group 1 Lower Risk Regimen Patients in this group will receive 3 phases of treatment In Phase A they will receive Navelbine and Herceptin intravenously every week for 12 weeks Upon completion of this therapy they will undergo surgery to remove the tumor Following surgery there will be a 6 week recovery period where no treatment will be received In Phase B patients will receive adriamycin doxorubicin and cytoxan cyclophosphamide intravenously every 3 weeks for 12 weeks for a total of 4 cycles Patients then may or may not receive Phase C depending upon physicians discretion during which they will receive herceptin intravenously every 3 weeks for 40 weeks If the physician decides that the patient needs radiation therapy it will commence after the completion of adriamycin and cytoxan
Group 2 Higher Risk Regimen Patients in this group will undergo four different phases of treatment Phase A is identical to that of Group 1 herceptin and navelbine for 12 weeks followed by surgery as is Phase B adriamycin and cytoxan every 3 weeks for 12 weeks for a total of 4 cycles Phase C will consist of paclitaxel and herceptin weekly for a total of 12 weeks If the physician decides that radiation therapy should be performed it will commence within 6 weeks of the last dose of paclitaxel and herceptin In Phase D patients will receive herceptin intravenously every three weeks for 28 weeks
The following procedures and tests will be performed during this study During Phase A Every week blood work Every 3 weeks physical exam tumor assessment and bloodwork During Phase B Every 3 weeks physical exam and blood work At the start of Phase B and C physical exam EKG MUGA scan or echocardiogram and bloodwork During Phase C Every 3 weeks for High risk patients and every 3 months for low risk patients physical exam and blood work End of Phase C MUGA scan or echocardiogram Phase C and D every 3 months physical exam EGK MUGA scan or echocardiogram and bloodwork
At the end of the study patients will undergo a physical exam EKG MUGA scan or echocardiogram and bloodwork
Depending upon the patients risk level as assessed by the treating physician they will be treated similarly to one of two regimens The first 8 months of both regimens are the same consisting of 12 weeks of herceptin and navelbine followed by surgery and then 4 cycles of adriamycin and cytoxan The treatment following these 8 months will depend upon the health risk to the patient and will be determined by both the patient and treating physician
Group 1 Lower Risk Regimen Patients in this group will receive 3 phases of treatment In Phase A they will receive Navelbine and Herceptin intravenously every week for 12 weeks Upon completion of this therapy they will undergo surgery to remove the tumor Following surgery there will be a 6 week recovery period where no treatment will be received In Phase B patients will receive adriamycin doxorubicin and cytoxan cyclophosphamide intravenously every 3 weeks for 12 weeks for a total of 4 cycles Patients then may or may not receive Phase C depending upon physicians discretion during which they will receive herceptin intravenously every 3 weeks for 40 weeks If the physician decides that the patient needs radiation therapy it will commence after the completion of adriamycin and cytoxan
Group 2 Higher Risk Regimen Patients in this group will undergo four different phases of treatment Phase A is identical to that of Group 1 herceptin and navelbine for 12 weeks followed by surgery as is Phase B adriamycin and cytoxan every 3 weeks for 12 weeks for a total of 4 cycles Phase C will consist of paclitaxel and herceptin weekly for a total of 12 weeks If the physician decides that radiation therapy should be performed it will commence within 6 weeks of the last dose of paclitaxel and herceptin In Phase D patients will receive herceptin intravenously every three weeks for 28 weeks
The following procedures and tests will be performed during this study During Phase A Every week blood work Every 3 weeks physical exam tumor assessment and bloodwork During Phase B Every 3 weeks physical exam and blood work At the start of Phase B and C physical exam EKG MUGA scan or echocardiogram and bloodwork During Phase C Every 3 weeks for High risk patients and every 3 months for low risk patients physical exam and blood work End of Phase C MUGA scan or echocardiogram Phase C and D every 3 months physical exam EGK MUGA scan or echocardiogram and bloodwork
At the end of the study patients will undergo a physical exam EKG MUGA scan or echocardiogram and bloodwork
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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