Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer|
- To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
- To evaluate signs and symptoms of cardiotoxicity.
- Annual assessment of recurrent disease.
- Overall survival and disease specific survival.
|Study Start Date:||January 2007|
|Study Completion Date:||October 2007|
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:
- to receive one year of trastuzumab treatment and annual follow-up for 5 years
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427427
|United States, California|
|Revlon/UCLA Breast Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Helena R Chang, M.D, Ph.D.||Revlon/UCLA Breast Center|