Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00496808
First received: July 3, 2007
Last updated: April 19, 2012
Last verified: April 2012

July 3, 2007
April 19, 2012
March 2005
November 2010   (final data collection date for primary outcome measure)
  • Percent Change in Proliferation as Measured by Ki-67 [ Time Frame: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Achieving Documented Change in Proliferation [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ] [ Designated as safety issue: No ]
    Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.
Not Provided
Complete list of historical versions of study NCT00496808 on ClinicalTrials.gov Archive Site
Mean Percent of Ki-67 [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ] [ Designated as safety issue: No ]
Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.
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Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ductal Carcinoma In Situ
Drug: Herceptin (Trastuzumab)
8 mg/kg IV Over 90 Minutes
Other Name: Trastuzumab
Experimental: Herceptin
8 mg/kg intravenously (IV) Over 90 Minutes
Intervention: Drug: Herceptin (Trastuzumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00496808
2004-0701
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Henry Kuerer, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP