Status:
COMPLETED
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Lead Sponsor:
Cynthia Owusu, MD
Conditions:
Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * To evaluate the 3-year cumulative incidence of cardiac events in women 60 years and older with HER2-positive breast cancer who receive single agent trastuzumab (Herceptin®) in ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the breast
- Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing.
- Life expectancy \> 6 months
- ECOG performance status ≤ 2
- Node positive disease irrespective of tumor size
- Node negative disease:
- TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status
- Baseline LVEF ≥ lower limit of normal for a particular institution
- Complete surgical removal of invasive cancer by mastectomy or lumpectomy
- Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms.
- Adequate bone marrow function as indicated by the following:
- ANC \>1000/µL
- Platelets ≥100,000/µL
- Hemoglobin \>10 g/dL
- Adequate liver function, as indicated by bilirubin ≤1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine ≤1.5 x ULN
- AST or ALT \<2 x ULN unless related to primary disease.
- Signed informed consent
Exclusion
- Enrollment after more than 120 days from the last day of mastectomy or lumpectomy
- Patients able to tolerate and willing to receive chemotherapy
- Prior chemotherapy for current malignancy
- Prior herceptin therapy
- Active cardiac disease
- Myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
- Angina pectoris requiring anti-anginal treatment
- Documented congestive heart failure (CHF)
- Current use of any therapy specifically for CHF
- Cardiac arrhythmia requiring medication
- Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg)
- Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
- Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
- Past cardiac disease
- Prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
- Prior history of CHF
- History of cardiomyopathy
- Other diseases and conditions
- Evidence of metastatic breast cancer (clinical or radiological evidence)
- Active infection
- Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Hypersensitivity to trastuzumab
Key Trial Info
Start Date :
February 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00796978
Start Date
February 5 2009
End Date
February 26 2020
Last Update
May 1 2024
Active Locations (11)
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1
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
2
Wake Forrest
Winston-Salem, North Carolina, United States, 27157
3
Lake/University Seidman Cancer Center
Cleveland, Ohio, United States, 44060
4
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065