Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer

OBJECTIVES:

• Determine the safety, especially the cardiac safety, of doxorubicin HCl liposome and trastuzumab (Herceptin) as first- or second-line therapy in women with metastatic, inflammatory, or locally advanced breast cancer.

OUTLINE: Patients are stratified according to prior anthracycline therapy (yes vs no).

Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed for at least 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced, inflammatory, or metastatic adenocarcinoma of the breast that has been treated with no more than 1 prior systemic cytotoxic regimen
• Overexpression of HER2 protein (2+ or 3+)
• Evaluable disease
• History of brain metastases allowed if off steroids and asymptomatic, with a 3 month or greater interval since last dose of brain irradiation, and no evidence of progression
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

• AST or ALT no greater than 4 times ULN

Cardiovascular:

• Adequate cardiac function
• LVEF at least 50% predicted or lower limit of normal

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent medical or psychological condition that would preclude study compliance
• No history of hypersensitivity to anthracyclines, eggs, or egg products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior trastuzumab (Herceptin) allowed

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior antineoplastic therapy
• No more than 1 prior systemic cytotoxic regimen for locally advanced, metastatic, or inflammatory breast cancer
• No prior anthracyclines greater than 240 mg/m2
• No other concurrent antineoplastic agents
• No concurrent treatment with other liposomal products other than doxorubicin HCl liposome

Endocrine therapy:

• See Disease Characteristics
• At least 3 weeks since prior hormonal agents
• No concurrent hormonal therapy

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Other:

• At least 3 weeks since other prior investigational drugs