PS-341 in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed invasive breast cancer
• •* Clinical and/or radiological evidence of stage IV disease
• •Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
• •At least 1 unidimensionally measurable lesion
• •* At least 20 mm by conventional techniques
• •* At least 10 mm by spiral CT scan
• •* No bone metastases as only measurable site
• •* Pleural or peritoneal effusions not acceptable as measurable disease
• •No known brain metastases
• •Hormone receptor status:
• •* Estrogen receptor-negative
• •* Estrogen receptor-positive
• •Female
• •Performance status - ECOG 0-2
• •Performance status - Karnofsky 60-100%
• •More than 12 weeks
• •WBC at least 3,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Bilirubin normal
• •AST or ALT no greater than 2.5 times upper limit of normal
• •Creatinine normal
• •Creatinine clearance at least 60 mL/min
• •No acute ischemia or significant conduction abnormality by EKG
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •LVEF greater than 50%
• •No uncontrolled concurrent illness
• •No psychiatric illness or social situation that would preclude study
• •No ongoing or active infection
• •No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341
• •No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier-method contraception
• •See Chemotherapy
• •See Disease Characteristics
• •No more than 1 prior chemotherapy regimen for metastatic disease
• •* High-dose regimen or bone marrow transplantation considered 1 prior regimen
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• •Prior hormonal therapy for metastatic disease or in adjuvant setting allowed
• •Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion
• •At least 4 weeks since prior radiotherapy and recovered
• •At least 2 weeks since prior minor surgery and recovered
• •At least 4 weeks since prior major surgery and recovered
• •No other concurrent investigational agent
• •No other concurrent investigational or commercial agents or therapies to treat this malignancy