Breast Cancer Clinical Trial
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.
Full Description
OBJECTIVES:
Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer.
Determine the efficacy of this regimen in these patients.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven breast cancer
Metastatic disease OR
Locoregional relapse following optimal adjuvant therapy and regional treatment
HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH)
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
18 and over
Sex:
Female
Menopausal status:
Not specified
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 10 g/dL
Hepatic:
SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone
Bilirubin no greater than 1.5 times ULN
Renal:
BUN less than 1.5 times ULN
Creatinine less than 1.5 times ULN
Cardiovascular:
LVEF normal by radioisotope method
No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No known sensitivity to benzyl alcohol
No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Biologic therapy:
Not specified
Chemotherapy:
No prior doxorubicin greater than 240 mg/m2
Endocrine therapy:
Not specified
Radiotherapy:
Prior radiotherapy to left breast or chest wall allowed
Surgery:
Not specified
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There is 1 Location for this study
New York New York, 10016, United States
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