Clinical trial NCT00028639 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility 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