Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

Completed · Not applicable

Conditions studied: Ductal Carcinoma In Situ

In brief

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

Key facts

Study ID

NCT00496808

Run by

M.D. Anderson Cancer Center

People needed

69

Starts

2005-03-01

Expected to finish

2010-11-01

Last updated by the study team

2020-09-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must sign informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
• 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.
• 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.
• 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.
• Patients with history of cardiac arrhythmia will be eligible for study after being seen by cardiology and deemed good candidates for participation.
• Women of child bearing potential must have a negative urine or serum pregnancy test.

You may not qualify if…

• Patients with a current known invasive breast cancer are not eligible for this study.
• All patients who are Her-2/neu negative will be ineligible for the study.
• Patients with history of congestive heart failure will be excluded.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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