Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent Change in Proliferation as Measured by Ki-67
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.
Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks
Henry Kuerer, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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