Clinical trial NCT00025584 (phase 2, status: completed)
Conditions: recurrent breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        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