lack of accrual

The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy.

Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible.

Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.

Study Phase- Phase II Study Type- Interventional Study Design-

This is an open label, non-randomized phase II study in patients with non-metastatic HER-2 positive breast cancer by FISH diagnosed in 2004 or thereafter. Potential patients will sign a written ICF prior to completing a questionnaire designed to determine what factors may affect a patient's acceptance of Herceptin® treatment. After answering the questionnaire, patients will be given the following options:

1. to receive one year of trastuzumab treatment and annual follow-up for 5 years
2. to decline trastuzumab treatment but serve as a comparison group member for monitoring safety and effectiveness of trastuzumab and to have annual follow-up for 5 years

Inclusion Criteria:

1. Confirmed non-metastatic infiltrating carcinoma of the breast.

2. HER-2 amplified (FISH +) determination in 2004 or thereafter.

3. ECOG performance status 0-2.

4. Patients 18 years of age or older.

5. HER-2 status is determined by FISH test.

6. The following criteria are applicable to the trastuzumab treatment group:

   • Normal LVEF as determined by ECHO or MUGA. If baseline LVEF > 75%, then LVEF shall be repeated to determine if falsely elevated.
   • Adequate bone marrow function as indicated by the following: ANC >1500/mL, Platelets >/=100,000/mL, Hemoglobin >9 g/dL
   • Adequate renal function,as indicated by serum creatinine \