Clinical trial NCT00281697 (phase 3, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bevacizumab, placebo, standard chemotherapy
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [Ta]
Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form.

          -  ≥ 18 years of age.

          -  Histologically confirmed carcinoma of the breast with measurable or non-measurable
             metastatic disease that has progressed (patients with a history of brain metastasis
             are eligible for study participation [USA only], as long as their brain metastases
             have been treated and they have no evidence of progression or hemorrhage after
             treatment and no ongoing requirement for dexamethasone).

          -  Progression of disease during or following administration of one (non-investigational)
             chemotherapy regimen administered in the first-line setting.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  For women of childbearing potential, use of an effective means of non-hormonal
             contraception.

          -  Life expectancy ≥ 3 months.

          -  Willingness and capacity to comply with study and follow-up procedures.

        Exclusion Criteria:

          -  Prior hormonal therapy only as treatment for metastatic disease without chemotherapy.
             Patients must have received chemotherapy for their metastatic disease in the
             first-line setting. Hormone therapy alone is not allowed.

          -  For subjects who have received prior anthracycline-based therapy, documentation of
             left ventricular ejection fraction < 50% by either multiple gated acquisition (MUGA)
             or echocardiogram (ECHO).

          -  Treatment with more than one prior cytotoxic regimen for metastatic breast cancer
             (MBC).

          -  HER2-positive status (patients who have unknown HER2 status, and for whom
             determination of HER2 status is not possible, are eligible for this study).

          -  Unknown estrogen receptor (ER) and progesterone receptor (PR) status.

          -  Radiation therapy other than for palliation or brain metastasis, biologic therapy, or
             chemotherapy for MBC within 21 days prior to Day 0 (Day 1 of Cycle 1 of treatment).

          -  Prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF)
             pathway-targeted therapy.

          -  Untreated brain metastasis.

          -  Inadequately controlled hypertension.

          -  Unstable angina.

          -  New York Heart Association Grade II or greater congestive heart failure (CHF).

          -  History of myocardial infarction within 6 months prior to Day 0 (the day of the first
             bevacizumab/placebo infusion).

          -  History of stroke or transient ischemic attack within 6 months prior to Day 0.

          -  Clinically significant peripheral vascular disease.

          -  Evidence of bleeding diathesis or coagulopathy.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0; anticipation of need for major elective surgical procedure during the
             study.

          -  Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days
             prior to Day 0.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0.

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

          -  History of anaphylactic reaction to monoclonal antibody therapy not controlled with
             treatment premedication.

          -  History of other malignancies within 5 years of Day 0, except for tumors with a
             negligible risk for metastasis or death, such as adequately controlled basal cell
             carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

          -  inadequate organ function.

          -  Pregnancy (positive serum pregnancy test) or lactation.

          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or renders the subject at high risk from treatment
             complications.