Clinical trial NCT00546156 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: doxorubicin, cyclophosphamide, paclitaxel, bevacizumab
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Documented primary invasive breast cancer by histologic assessment

          -  Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard
             immunohistochemical methods. Tumors must be negative for HER2. There must be
             sufficient sample for further protocol-specified immunohistochemical analysis

          -  Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in
             protocol

          -  18 year of age or older

          -  Performance status of 0 or 1 by ECOG criteria

          -  Use of an effective means of contraception in subjects of childbearing potential

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days prior to starting therapy.

          -  Patients taking exogenous sex-steroid hormone treatments for any reason at the time of
             diagnosis must discontinue all hormonal treatments at least 2 weeks prior to
             enrollment

          -  Patients must have preoperative treatment within 60 days of initial diagnosis of
             breast cancer

          -  No other malignancy that requires on-going treatment

          -  Normal organ function as outlined in the protocol

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy or radiation for the current breast cancer

          -  Patients with inflammatory breast cancer

          -  HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be
             negative by FISH

          -  Known metastatic (Stage IV) disease

          -  Other investigational agents within 4 weeks prior to the start of study treatment

          -  Life expectancy of less than 6 months

          -  Peripheral neuropathy greater than or equal to grade 2

          -  Inadequately controlled hypertension

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  NYHA grade II or greater congestive heart failure

          -  History of prior myocardial infarction

          -  History of unstable angina within 12 months prior to study enrollment

          -  Any history of stroke or transient ischemic attack at any time

          -  Known CNS disease

          -  Significant vascular disease

          -  Symptomatic peripheral vascular disease

          -  Evidence of significant bleeding within 6 months of study; any serious non-healing
             wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal
             perforation or intra-abdominal abscess within the past 6 months; any major surgical
             procedure within 28 days prior to randomization or anticipation of need for major
             surgery during course of study.

          -  Known HIV positive

          -  Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue

          -  Pregnant of lactating

          -  Known hypersensitivity to any component of bevacizumab