Overview

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objectives: - 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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Trastuzumab
Criteria
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.