Clinical trial NCT00445406 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bevacizumab + doxorubin hydrochloride liposme, bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytologically or histologically confirmed breast cancer

               -  Metastatic OR locally recurrent disease

               -  Unresectable disease

               -  Not amenable to radiotherapy

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

               -  Measurable disease must be outside irradiated areas

          -  ErbB2-negative disease by immunohistochemistry (negative or 1+) or fluorescent in situ
             hybridization (FISH)

          -  No known CNS metastases, even if previously treated

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Female

          -  Menopausal status not specified

          -  WHO performance status 0-1

          -  LVEF ≥ 55%

          -  Hemoglobin ≥ 10.0 g/dL

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin < 2 times upper limit of normal (ULN)

          -  ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

          -  Alkaline phosphatase (AP) ≤ 2.5 times ULN

               -  AP > 2.5 times ULN and ≤ 6 times ULN allowed if ALT ≤ 1.5 times ULN

               -  AP > 6 times ULN allowed if ALT normal

          -  Creatinine ≤ 1.5 times ULN

          -  Proteinuria < 2+ by dipstick OR protein ≤ 1 g/24hr-urine collection

          -  INR ≤ 1.5 OR Quick ≥ 70%

          -  aPTT ≤ 1.5 times ULN

          -  No peripheral neuropathy > grade 2

          -  No history or evidence of hereditary bleeding diathesis or coagulopathy with the risk
             of bleeding

          -  No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
             and/or diastolic BP > 100 mm Hg, measured repeatedly at > 2 visits despite adequate
             treatment with ≥ 2 different antihypertensive drugs

          -  No clinically significant cardiovascular disease, including the following:

               -  Cerebrovascular accident or stroke within the past 6 months

               -  Myocardial infarction within the past 6 months

               -  Unstable angina

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

               -  Serious cardiac arrhythmia (e.g., ventricular arrhythmia, high-grade
                  atrioventricular-block) not controlled by medication or requiring medication
                  which might interfere with regularity of the study treatment

          -  No serious nonhealing wound, active peptic ulcer, nonhealing bone fracture, or
             bleeding skin metastases

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No active infection requiring IV antibiotics

          -  No known hypersensitivity to any of the study drugs or excipients

          -  No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human or humanized antibodies

          -  No evidence of any other disease that contraindicates the use of an investigational
             drug, that may affect patient compliance with study routines, or places the patient at
             high risk for treatment-related complications including, but not limited to, the
             following:

               -  Metabolic dysfunction

               -  Physical examination finding

               -  Psychological dysfunction

               -  Clinical laboratory finding giving reasonable suspicion of a disease or condition

          -  No known CNS disease unrelated to cancer (e.g., uncontrolled seizures), unless
             adequately treated with standard medical therapy

          -  No high-risk factors for bleeding, including the following:

               -  Coagulation parameters outside range

               -  Need for concurrent anticoagulant therapy

               -  Insufficient time gap after surgical procedures

          -  No other malignancy within the past 5 years except for adequately treated basal cell
             or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

          -  No significant traumatic injury within the past 28 days

          -  No known HIV positivity

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study therapy

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy for metastatic or inoperable locally recurrent breast cancer

          -  No prior bevacizumab or other anti-vascular endothelial growth factor drug therapy

          -  No prior radiotherapy involving the heart (usual irradiation dose to breast or chest
             wall allowed)

          -  More than 12 months since prior neoadjuvant or adjuvant chemotherapy

          -  No neoadjuvant or adjuvant doxorubicin hydrochloride with cumulative dose > 360 mg/m²
             or epirubicin hydrochloride with cumulative dose > 720 mg/m²

          -  More than 6 months since prior adjuvant radiotherapy

          -  More than 28 days since prior major surgical procedure with high risk of bleeding

          -  More than 24 hours since prior minor surgical procedures

          -  More than 10 days since prior acetylsalicylic acid (> 325 mg/day) or clopidogrel
             bisulfate (> 75 mg/day)

          -  More than 10 days since prior and no concurrent use of full-dose oral or parenteral
             anticoagulants or thrombolytic agents for therapeutic purposes

               -  Prophylactic use of anticoagulants allowed (e.g., for maintenance of venous
                  catheter)

          -  More than 30 days since prior investigational therapies or participation in other
             investigational studies

          -  No concurrent hormonal therapy

          -  No other concurrent antineoplastic or antitumor therapy

          -  No other concurrent investigational drugs

          -  No concurrent radiotherapy

          -  No concurrent nonsteroidal anti-inflammatory drugs with activity on platelets and
             gastric mucosa (e.g., dipyridamole, clopidogrel bisulfate, acetylsalicylic acid)

          -  No anticipated need for major surgery during the course of the study treatment