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Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast


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Ductal Carcinoma In Situ

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Trial Information

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
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.


Inclusion Criteria:



1. All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+
positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification
by fluorescence in situ hybridization (FISH) will be eligible for the study.

2. Patients must sign informed consent indicating that they are aware of the
investigational nature of the study, in keeping with institutional policy.

3. Those patients with history of other contralateral non-invasive and invasive breast
and non-breast malignancies are eligible to participate unless they have previously
received a doxorubicin dose of more than 400 mg/m2.

4. All patients should have adequate bone marrow function, as defined by peripheral
granulocyte count of > 1,500/mm3, and platelet count > 100,000 mm3. Patients must
have adequate liver function, with bilirubin within normal laboratory values. In
addition, patients should have adequate renal function, defined as serum creatinine <
2.0 mg/dl.

5. Patients with intact primary tumors will be eligible for this study. Patients who
have had their diagnostic biopsy at an outside facility but still have measurable
disease on presentation will be eligible.

6. Patients with history of cardiac arrhythmia will be eligible for study after being
seen by cardiology and deemed good candidates for participation.

7. Women of child bearing potential must have a negative urine or serum pregnancy test.

Exclusion Criteria:

1. Patients with a current known invasive breast cancer are not eligible for this study.

2. All patients who are Her-2/neu negative will be ineligible for the study.

3. Patients with history of congestive heart failure will be excluded.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent Change in Proliferation as Measured by Ki-67

Outcome Description:

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.

Outcome Time Frame:

Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks

Safety Issue:

No

Principal Investigator

Henry Kuerer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0701

NCT ID:

NCT00496808

Start Date:

March 2005

Completion Date:

November 2010

Related Keywords:

  • Ductal Carcinoma In Situ
  • Ductal Carcinoma In Situ
  • Breast Cancer
  • Herceptin
  • Trastuzumab
  • DCIS
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030