A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
Study Overview
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:
- 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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed non-metastatic infiltrating carcinoma of the breast.
- •HER-2 amplified (FISH +) determination in 2004 or thereafter.
- •ECOG performance status 0-
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
To evaluate acceptance rate of delayed adjuvant trastuzumab treatment.
To evaluate signs and symptoms of cardiotoxicity.
Secondary Outcomes
- Annual assessment of recurrent disease.
- Overall survival and disease specific survival.