Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
* Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
* Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
* ECOG performance status 0-1
* Adequate bone marrow reserve as indicated by:

  * ANC \> 1500/uL (without use of growth factors within 7 days)
  * Platelet count \> 100,000 (without transfusion in prior 7 days)
  * Hemoglobin \> 9.0 g/dL

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Locally recurrent disease amenable to resection with curative intent
* HER-2-positive breast cancer
* Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
* Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
* Investigational therapy within 4 weeks of first study drug administration
* Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
* Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
* Grade ≥ 2 neuropathy
* Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
* Severe conduction disturbance including clinically significant QTC prolongation \> 450 ms (unless pacemaker in place)
* Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
* Clinically relevant active infection
* Known positive serology for human immunodeficiency virus (HIV)