Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00427427
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 75
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Confirmed non-metastatic infiltrating carcinoma of the breast.
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HER-2 amplified (FISH +) determination in 2004 or thereafter.
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ECOG performance status 0-2.
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Patients 18 years of age or older.
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HER-2 status is determined by FISH test.
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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 </= 1.5 x ULN
- Adequate liver function, as indicated by total bilirubin </= 1.5 x ULN
- AST and ALT < 2 x ULN unless related to primary disease.
- If female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
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Signed informed consent has been obtained.
- Non-confirmed HER-2 positive by FISH infiltrating carcinoma of the breast.
- Evidence of metastatic disease.
- Previous trastuzumab treatment.
- Concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
- Patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
- Symptomatic intrinsic lung disease resulting in dyspnea at rest.
- Concurrent life-limiting disease with a life expectancy of less than one year.
- Pregnancy, nursing women, and fertile women who do not practice birth control.
- Inability to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate acceptance rate of delayed adjuvant trastuzumab treatment. To evaluate signs and symptoms of cardiotoxicity.
- Secondary Outcome Measures
Name Time Method Annual assessment of recurrent disease. Overall survival and disease specific survival.
Trial Locations
- Locations (1)
Revlon/UCLA Breast Center
🇺🇸Los Angeles, California, United States