Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00427427|
Recruitment Status : Terminated (lack of accrual)
First Posted : January 29, 2007
Last Update Posted : August 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Trastuzumab||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||October 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|