Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Metastatic (stage IV) disease
• Relapsed after 1 of the following prior therapy regimens\*:
• * Adjuvant therapy containing an anthracycline and a taxane
• * Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: \*No relapse within 12 months of initiation of prior therapy
• Measurable disease by CT scan or MRI
• * No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease
• Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy
• HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®)
• * MUGA or echocardiogram normal while on trastuzumab
• No known history of or current brain or leptomeningeal metastases
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• Over 18
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• WBC at least 3,000/mm\^3
• Neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10.0 g/dL
• No clinically significant abnormal hematological parameters
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
• AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
• Renal
• Creatinine no greater than 1.5 times ULN
• Cardiovascular
• See Disease Characteristics
• No myocardial infarction within the past 3 months
• No unstable angina pectoris
• No New York Heart Association class III or IV heart disease
• No uncontrolled arrhythmia
• No cardiac insufficiency
• No uncontrolled hypertension
• LVEF at least 50% OR at least lower limit of normal
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation
• No preexisting neuropathy (motor or sensory) greater than grade 2
• No clinically significant abnormal biochemical parameters
• No clinically significant active infection
• No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
• No other serious illness or medical condition
• No psychological illness or condition that would preclude study participation
• No other known condition that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• See Disease Characteristics
• More than 3 months since prior trastuzumab
• More than 2 weeks since prior growth factor therapy (i.e., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
• No concurrent systemic anticancer immune modulators
• Chemotherapy
• See Disease Characteristics
• Endocrine therapy
• See Disease Characteristics
• More than 4 weeks since prior hormonal therapy
• No concurrent anticancer hormonal therapy
• No concurrent chronic systemic steroids
• * Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment
• Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment
• Radiotherapy
• More than 30 days since prior radiotherapy
• No concurrent radiotherapy directed at target lesions
• Surgery
• At least 4 weeks since prior major surgery and recovered
• Other
• More than 30 days since prior investigational new drug
• More than 2 weeks since prior blood transfusion
• No other concurrent systemic anticancer agents, including immunosuppressive agents
• No other concurrent investigational agents
• Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment