Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial
- To evaluate the 3-year cumulative incidence of cardiac events in older women with
HER2-positive early stage breast cancer treated with adjuvant trastuzumab (Herceptin®).
- To evaluate the 3-year cumulative incidence of asymptomatic cardiac left ventricular
dysfunction in these patients.
- To assess the relation between physiologic markers of chronic heart failure and
trastuzumab-related cardiac dysfunction in these patients.
- To assess the relation between pro-inflammatory cytokines and trastuzumab-related
cardiac dysfunction in these patients.
- To determine the effect of this drug on the health-related quality of life and
functional, cognitive, and mental status of these patients.
- To determine the 3-year disease-free survival and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable
Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac
markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines
(interleukin-6 and tumor necrosis factor-α). Patients complete Quality of Life and Quality
of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental
status changes at baseline, weeks 26, and 52.
After completion of study therapy, patients are followed periodically for 4 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Three-year cumulative incidence of cardiac events
every 6 weeks during treatment
Cynthia Owusu, MD, MSC
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Duke University Medical Center||Durham, North Carolina 27710|
|UH-Monarch||Mayfield Heights, Ohio 44124|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|University Suburban Health Center||South Euclid, Ohio 44121|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|
|University of Miami, Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|Wake Forrest||Winston, North Carolina 27157|