Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496808
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2007-07-03
Brief Title:
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
Status:
COMPLETED
Status Verified Date:
2020-09
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:
Primary Objectives
To determine the effect of a single dose of Herceptin trastuzumab on the proliferation rate of Her-2neu over-expressing ductal carcinoma in situ DCIS
To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2neu over-expressing DCIS
To determine the effect of a single dose of Herceptin trastuzumab on the proliferation rate of Her-2neu over-expressing ductal carcinoma in situ DCIS
To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2neu over-expressing DCIS
Detailed Description:
Herceptin Trastuzumab stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow
As part of your standard care for DCIS you will have a complete routine physical exam a mammogram of both breasts and blood about 2 tablespoons will be drawn for routine tests Some of your leftover breast biopsy tissue will be tested for Her-2neu expression Blood will be drawn about 2-6 teaspoons to check if your bone marrow red blood cells kidney and liver are functioning well enough to have this treatment Women who are able to have children must have a negative blood pregnancy test before starting treatment
If you are eligible to take part in this study you will receive one dose of trastuzumab at least 2 weeks before your surgery The dose of trastuzumab will be given intravenously through a needle in a vein in your arm as a steady infusion over 90 minutes on an outpatient basis You will be checked during the infusion and for 1 hour after it is completed
You will have routine surgery for DCIS either segmental mastectomy mastectomy with or without reconstruction and possible sentinel lymph node biopsy approximately 14 to 28 days after being given Herceptin If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery After your surgery patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed
Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers substances which indicate the severity or spread of cancer cancer growth rate and apoptotic index cell death rate
This is an investigational study The FDA has approved trastuzumab for the treatment of breast cancer Up to 71 patients will take part in this study All will be enrolled at M D Anderson
As part of your standard care for DCIS you will have a complete routine physical exam a mammogram of both breasts and blood about 2 tablespoons will be drawn for routine tests Some of your leftover breast biopsy tissue will be tested for Her-2neu expression Blood will be drawn about 2-6 teaspoons to check if your bone marrow red blood cells kidney and liver are functioning well enough to have this treatment Women who are able to have children must have a negative blood pregnancy test before starting treatment
If you are eligible to take part in this study you will receive one dose of trastuzumab at least 2 weeks before your surgery The dose of trastuzumab will be given intravenously through a needle in a vein in your arm as a steady infusion over 90 minutes on an outpatient basis You will be checked during the infusion and for 1 hour after it is completed
You will have routine surgery for DCIS either segmental mastectomy mastectomy with or without reconstruction and possible sentinel lymph node biopsy approximately 14 to 28 days after being given Herceptin If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery After your surgery patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed
Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers substances which indicate the severity or spread of cancer cancer growth rate and apoptotic index cell death rate
This is an investigational study The FDA has approved trastuzumab for the treatment of breast cancer Up to 71 patients will take part in this study All will be enrolled at M D Anderson
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