A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer

Inclusion Criteria

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)