Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
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|ClinicalTrials.gov Identifier: NCT00496808|
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : May 18, 2012
Last Update Posted : May 18, 2012
- To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)
- To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS
|Condition or disease||Intervention/treatment||Phase|
|Ductal Carcinoma In Situ||Drug: Herceptin (Trastuzumab)||Not Applicable|
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-2/neu 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
8 mg/kg intravenously (IV) Over 90 Minutes
Drug: Herceptin (Trastuzumab)
8 mg/kg IV Over 90 Minutes
Other Name: Trastuzumab
- Percent Change in Proliferation as Measured by Ki-67 [ Time Frame: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks ]Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.
- Number of Participants Achieving Documented Change in Proliferation [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ]Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.
- Mean Percent of Ki-67 [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ]Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496808
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Henry Kuerer, MD, PhD||M.D. Anderson Cancer Center|