Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief summary
RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.
Detailed description
OBJECTIVES: * Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib. * Determine the toxic effects of this drug in these patients. * Determine the progression-free survival in patients treated with this drug. OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.
Interventions
DRUGbortezomib
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab \[Herceptin\]) for metastatic disease * Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study * No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib * No other prior malignancy within the past 5 years unless curatively treated and disease free * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Prior hormonal therapy for metastatic disease allowed * At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * Prior adjuvant therapy allowed * At least 4 weeks since prior investigational drugs and recovered * No other concurrent investigational or commercial agents or therapies for breast cancer * No concurrent combination antiretroviral therapy for HIV
Countries
United States
Outcome results
None listed