Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

OBJECTIVES:

Primary

• Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.

Secondary

• Determine the feasibility of this drug in these patients.
• Evaluate chemotherapy-induced toxicities in these patients.
• Assess the disease-free survival and overall survival of these patients.
• Study the geriatric covariates.
• Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.

After completion of study therapy, patients are followed up periodically for 2 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast

• Metastatic disease as confirmed by ≥ 1 of the following:

• Histology or cytology
• Radiology
• Elevated CA 15-3 levels
• No HER2/neu overexpression by IHC or FISH
• Measurable (≥ 10 mm) or evaluable disease

• Bone lesions or isolated pleural effusion allowed
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Postmenopausal
• Life expectancy > 3 months
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Alkaline phosphatase ≤ 5 times ULN
• Bilirubin ≤ 2 times ULN
• Creatinine clearance ≥ 30 mL/min
• LVEF ≥ 50%
• No congestive heart failure or other uncontrolled cardiac disease
• No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
• No prior hypersensitivity to anthracyclines
• No psychological, familial, social, or geographical reason that would preclude study follow-up
• No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic disease
• Prior adjuvant chemotherapy allowed

• No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
• No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
• More than 30 days since prior participation in another clinical trial