Status:
TERMINATED
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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. W...
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 2...
Eligibility Criteria
Inclusion
- Confirmed non-metastatic infiltrating carcinoma of the breast.
- HER-2 amplified (FISH +) determination in 2004 or thereafter.
- ECOG performance status 0-2.
- Patients 18 years of age or older.
- HER-2 status is determined by FISH test.
- 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.
- Signed informed consent has been obtained.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00427427
Start Date
January 1 2007
End Date
October 1 2007
Last Update
August 1 2016
Active Locations (1)
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1
Revlon/UCLA Breast Center
Los Angeles, California, United States, 90095