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Study Summary
No. 2004-0701:.......Breast......Henry Kuerer......Surgical Oncology
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Study Summary Title
Study Summary
Number:
2004-0701
Study Title:Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
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Physician New Patient Referral
Name:Henry KuererPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Surgical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-5043
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:N/A
Phase of Study:N/AReturn
Visit:
Standard of follow-up Care
Treatment
Agents:
HerceptinHome Care:None.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Length of hospital stay for surgery is 1-2 days.
Description/
Intervention:
The goal of this clinical research study is to find out if a single dose of the
drug Herceptin (trastuzumab) given before surgery can kill cancer cells or slow
the growth of cancer cells in women who have DCIS.
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Study Objectives / Outcomes
1.1 To determine the effect of a single dose of Herceptin on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS).

1.2 To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing ductal carcinoma in situ (DCIS).
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Study Status Information
Study Activation / Registration Date:03/17/2005
IRB Review and Approval Date:10/20/2004
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 400mg/m*2.

4) All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm*3, and platelet count > 100,000 mm*3. Patients must have adequate liver function, with bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine <2.0mg%.

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.

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Links
Registration Number: NCT00496808
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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