Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00496808

Purpose

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 ductal carcinoma in situ (DCIS)

Condition	Intervention
Ductal Carcinoma In Situ	Drug: Herceptin (Trastuzumab)

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	71
Study Start Date:	March 2005
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Herceptin (Trastuzumab)	Drug: Herceptin (Trastuzumab) 8 mg/kg IV Over 90 Minutes

Detailed Description:

Trastuzumab (Herceptin) 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496808

Contacts

Contact: Henry Kuerer, MD, PhD

713-745-5043

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Henry Kuerer, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Henry Kuerer, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Henry Kuerer, MD, PhD/Professor )
Study ID Numbers:	2004-0701
Study First Received:	July 3, 2007
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00496808
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ductal Carcinoma In Situ
Breast Cancer
Herceptin
Trastuzumab
DCIS

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Trastuzumab
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents

Therapeutic Uses
Neoplasms, Ductal, Lobular, and Medullary
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009