The purpose of this study is to evaluate the efficacy and safety of treatment with
imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without
bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have
not received chemotherapy or have received one non-taxane based chemotherapy for metastatic
breast cancer.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Clearview Cancer Center, Huntsville, Alabama 35805, United States
Alta Bates Summit Medical Center, Berkeley, California 94704, United States
Southbay Oncology Hematology Partners, Campbell, California 95008, United States
Cancer Care Associates, Fresno, California 93720, United States
Memorial Miller Hospital, Long Beach, California 90806, United States
St. Joseph Hospital, Orange, California 92868, United States
Desert Regional Comprehensive Cancer Center, Palm Springs, California 92262, United States
UC San Diego, San Diego, California 92093, United States
Redwood Regional Medical Group, Santa Rosa, California 95403, United States
Univ. Colorado at Denver, Aurora, Colorado 80045, United States
Connecticut Oncology & Hematology, Torrington, Connecticut 06790, United States
Medical Oncology Hematology, Waterbury, Connecticut 06708, United States
Florida Oncology Associates, Jacksonville, Florida 32256, United States
Hematology Oncology Associates, Port St. Lucie, Florida 34952, United States
H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States
Northeast Georgia Cancer Care, Athens, Georgia 30607, United States
Emory University, Atlanta, Georgia 30322, United States
Peachtree Hematology Oncology, Atlanta, Georgia 30318, United States
Northeast Georgia Medical Center, Gainesville, Georgia 30501, United States
Central Georgia Cancer Care, Macon, Georgia 31201, United States
Summit Cancer Care, Savannah, Georgia 31405, United States
Kootenai Medical Center, Post Falls, Idaho 83854, United States
Ingalls Memorial Hospital, Chicago, Illinois 60426, United States
Rush University, Chicago, Illinois 60612, United States
Mid Illinois Hematology & Oncology, Normal, Illinois 61761, United States
Cancer Treatment Centers of America, Zion, Illinois 60099, United States
Community Hospitals of Indiana, Indianapolis, Indiana 46268, United States
Indiana University, Indianapolis, Indiana 46202, United States
Horizon Oncology Center, Lafayette, Indiana 47905, United States
Cancer Center of Kansas, Wichita, Kansas 67214, United States
Montgomery Cancer Care, Mount Sterling, Kentucky 40353, United States
Michigan State University, East Lansing, Michigan 48823, United States
New Mexico Cancer Center, Albuquerque, New Mexico 87109, United States
Prohealth Associates, Lake Success, New York 11402, United States
Stony Brook University, Stony Brook, New York 11794, United States
Carolinas Hematology/Oncology, Charlotte, North Carolina 28203, United States
Moses Cone Medical System, Greensboro, North Carolina 27403, United States
Case Western Reserve Univ., Cleveland, Ohio 44106, United States
Mercy Physicians of Oklahoma, Oklahoma City, Oklahoma 73120, United States
Cancer Care Associates, Tulsa, Oklahoma 74136, United States
Grand River Regional Cancer Centre, Kitchener, Ontario N2G 1G3, Canada
Stronach Regional Cancer Centre at Southlake, Newmarket, Ontario L3Y 2P9, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario K1H 8L6, Canada
Sunnybrook Health Services Centre, Toronto, Ontario M4N 3M5, Canada
Kaiser Northwest, Portland, Oregon 97232, United States
Pinnacle Health, Harrisburg, Pennsylvania 17110, United States
Penn. State Univ., Hershey, Pennsylvania 17033, United States
McGill University, Montreal, Quebec H2W 1S6, Canada
The Jones Clinic, Germantown, Tennessee 38138, United States
The West Clinic, Memphis, Tennessee 38120, United States
Scott & White Healthcare, Temple, Texas 76508, United States
Northern Utah Associates, Ogden, Utah 84403, United States
Peninsula Cancer Institute, Newport News, Virginia 23601, United States
Medical Oncology Associates, Spokane, Washington 99208, United States
Northwest Medical Specialties, Tacoma, Washington 98405, United States
Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92.
Goldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9.
Herbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. Epub 2001 Feb 22. Review.