Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

NCT00496808 | Completed Results

• 1 other identifier: 2004-0701
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ductal Carcinoma In Situ

Keywords

Ductal Carcinoma In Situ; Breast Cancer; Herceptin; Trastuzumab; DCIS

Outcome Measures

Primary Outcomes (2)

• Percent Change in Proliferation as Measured by Ki-67

  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.

  Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks

• Number of Participants Achieving Documented Change in Proliferation

  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.

  Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks

Secondary Outcomes (1)

• Mean Percent of Ki-67

  Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks

Study Arms (1)

Herceptin

EXPERIMENTAL

8 mg/kg intravenously (IV) Over 90 Minutes

Drug: Herceptin (Trastuzumab)

Interventions

Herceptin (Trastuzumab) DRUG

8 mg/kg IV Over 90 Minutes

Also known as: Trastuzumab

Herceptin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Raphael E Pollock,PHD/Professor Emeritus, Surgical Oncology
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

(713) 792-6928

Study Officials

• Henry Kuerer, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: March 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 23, 2020
• Results First Posted: May 18, 2012

Record last verified: 2020-09

Locations

US (1)