Clinical trial NCT00262067 (phase 3, status: unknown status)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bevacizumab, placebo, 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, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the breast, with
             measurable or non-measurable locally recurrent or metastatic disease.

          -  Signed Informed Consent Form.

          -  Age ≥ 18 years.

          -  For women of childbearing potential, use of accepted and effective method of
             non-hormonal contraception.

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

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

          -  For anthracycline cohort only: Adequate left ventricular function at study entry,
             defined as a left ventricular ejection fraction (LVEF) ≥ 50% by either multigated
             acquisition (MUGA) scan scan or echocardiography (ECHO).

          -  For subjects who have received recent radiation therapy, recovery prior to baseline
             (Day 0) from any significant (Grade ≥ 3) acute toxicity.

        Exclusion Criteria:

          -  Unknown human epidermal growth factor receptor 2 (HER2) status or known HER2-positive
             status.

          -  Prior chemotherapy for locally recurrent or metastatic disease.

          -  Prior hormonal therapy less than 1 week prior to Day 0.

          -  Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0.

          -  For anthracycline cohort only: Prior anthracycline as part of neoadjuvant or adjuvant
             therapy for localized breast cancer.

          -  Investigational therapy within 28 days of Day 0.

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

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

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

          -  Known brain or other central nervous system (CNS) metastases.

          -  Blood pressure of > 150/100 mmHg.

          -  Unstable angina.

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

          -  History of myocardial infarction within 6 months prior to Day 0.

          -  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.

          -  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.

          -  Pregnancy (positive serum pregnancy test) or lactation.

          -  Inadequate organ function, as evidenced by any of the following laboratory values:
             Absolute neutrophil count < 1500/uL; platelet count < 100,000/uL; total bilirubin >
             1.5 mg/dL; alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal (ULN) (>
             5x ULN in subjects with known liver or, for alkaline phosphatase elevations, bone
             involvement); alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known bone
             involvement); serum creatinine > 2.0 mg/dL; partial thromboplastin time (PTT) and/or
             either international normalized ratio (INR) or prothrombin time (PT) > 1.5x upper
             limit of normal (except for subjects receiving anti-coagulation therapy); urine
             protein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick for
             proteinuria >/= 1+ at screening followed by 24-hour urine collection demonstrating > 1
             g protein/24 hr for ex-U.S. subjects.

          -  Uncontrolled serious medical or psychiatric illness.

          -  Active infection requiring intravenous (iv) antibiotics at Day 0.

          -  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
             (subjects with a history of bilateral breast cancer will be eligible).