Clinical trial NCT00654836 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: carboplatin, abi-007
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed primary adenocarcinoma of the breast

               -  Locally recurrent or metastatic disease

          -  Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to
             receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past

          -  Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded) as > 20 mm by conventional
             techniques or as > 10 mm by spiral CT scan.

          -  No known CNS disease

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Postmenopausal status not specified

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  Life expectancy > 12 weeks

          -  WBC ≥ 3,000/mcL

          -  Absolute neutrophil count ≥ 1,500/mcL

          -  Platelet count ≥ 100,000/mcL

          -  Total bilirubin normal

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence
             of liver metastasis)

          -  Creatinine ≤ 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other concurrent malignancies within the past 5 years except basal cell or squamous
             cell skin cancer or carcinoma in situ of the cervix

        Exclusion criteria:

          -  Pre-existing neuropathy ≥ grade 1

          -  Uncontrolled intercurrent illness including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Serious, non-healing wound, ulcer, or bone fracture

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

          -  Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg
             and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association class II-IV congestive heart failure

          -  History of myocardial infarction or unstable angina within the past 6 months

          -  History of stroke or transient ischemic attack within the past 6 months

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Significant traumatic injury within the past 28 days

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within the past 6 months

          -  Proteinuria, as demonstrated by either urine protein:creatinine ratio ≥ 1.0 OR urine
             dipstick for proteinuria ≥ 2+

               -  Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline
                  must demonstrate 24-hour urine protein ≤ 1g

          -  History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle
             formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients,
             or chemically similar agents

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  No prior chemotherapy for locally recurrent or metastatic disease

          -  Prior neoadjuvant or adjuvant chemotherapy allowed

          -  More than 1 week since prior core biopsy or other minor surgical procedure, excluding
             placement of a vascular access device

          -  More than 4 weeks since prior and no concurrent major surgical procedure or open
             biopsy

          -  More than 4 weeks since prior radiotherapy

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

          -  At least 1 year since prior taxane regimen

          -  No other concurrent investigational agents

          -  Concurrent anticoagulation allowed, provided the following criteria are met:

               -  Stable dose of warfarin or low molecular weight heparin

               -  INR within desired range (2-3)

               -  No evidence of active bleeding or coagulopathy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal
             therapy