NCT00496808

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Ductal Carcinoma In Situ

Interventions

Type	Name	Description
DRUG	Herceptin (Trastuzumab)	8 mg/kg IV Over 90 Minutes

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-07-04
• Last updated: 2020-09-23
• Results posted: 2012-05-18

Locations

1 site across 1 country: United States