A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
Helena R Chang, M.D, Ph.D.
Revlon/UCLA Breast Center
United States: Institutional Review Board
|Revlon/UCLA Breast Center||Los Angeles, California 90095|