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Sponsored by: |
University of California, Los Angeles |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00427427 |
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 | Intervention | Phase |
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Breast Cancer |
Drug: Trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer |
Estimated Enrollment: | 75 |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following criteria are applicable to the trastuzumab treatment group:
Exclusion Criteria:
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 |
Study ID Numbers: | IRB# 06-05-104, H3754s |
Study First Received: | January 25, 2007 |
Last Updated: | October 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00427427 |
Health Authority: | United States: Institutional Review Board |
non-metastatic breast cancer HER-2 positive breast cancer Herceptin (trastuzumab) |
delayed adjuvant therapy acceptability rate non-metastatic, HER-2 positive breast cancer |
Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |