Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial
65 Years
N/A
Female
Breast Cancer
Trial Information
Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial
OBJECTIVES:
Primary
- 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®).
Secondary
- 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
toxicity.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Early stage disease (any T, any N, M0)
- No metastatic disease
- Must have undergone complete surgical removal of invasive cancer by mastectomy or
lumpectomy with either sentinel or axillary lymph node dissection within the past 84
days
- Must have received either whole or partial breast radiotherapy by external beam
or brachytherapy after completion of primary surgery
- Unable or unwilling to receive chemotherapy
- HER2-positive, defined 3+ by IHC or HER2 gene amplification by FISH
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy > 6 months
- ANC > 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin > 10 g/dL
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- AST or ALT < 2 times ULN (unless related to primary disease)
- LVEF normal
- Ejection fraction ≥ 50%
- No active cardiac disease, including any of the following:
- Prior myocardial infarction (MI) (asymptomatic changes suggestive of old MI on
EKG allowed)
- Angina pectoris requiring anti-anginal treatment
- Documented CHF
- Cardiac arrhythmia requiring medication
- Uncontrolled hypertension (diastolic BP > 100 mm Hg or systolic BP > 200 mm Hg)
- Clinically significant valvular abnormality or pericardial effusion (associated
with NYHA class II-IV symptoms)
- No history of CHF or cardiomyopathy
- No concurrent or prior malignancies within the past 5 years, except adequately
treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the
cervix
- No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs
resulting in dyspnea at rest
- No active infection
- No emotional limitations
- No hypersensitivity to trastuzumab (Herceptin®)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for this disease
- No prior trastuzumab (Herceptin®)
- Adjuvant trastuzumab during radiotherapy allowed
- No concurrent therapy specifically for congestive heart failure (CHF)
- No other concurrent chemotherapy or biologic agents
- Hormonal therapy for patients with hormone receptor-positive disease allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Three-year cumulative incidence of cardiac events
Outcome Time Frame:
every 6 weeks during treatment
Safety Issue:
Yes
Principal Investigator
Cynthia Owusu, MD, MSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE10107
NCT ID:
NCT00796978
Start Date:
November 2008
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- HER2-positive breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
