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Brief Title: Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
Official Title: 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
Study ID: NCT01256762
Brief Summary: 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.
Detailed Description: Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clearview Cancer Center, Huntsville, Alabama, United States
Alta Bates Summit Medical Center, Berkeley, California, United States
Southbay Oncology Hematology Partners, Campbell, California, United States
Cancer Care Associates, Fresno, California, United States
Memorial Miller Hospital, Long Beach, California, United States
St. Joseph Hospital, Orange, California, United States
Desert Regional Comprehensive Cancer Center, Palm Springs, California, United States
UC San Diego, San Diego, California, United States
Redwood Regional Medical Group, Santa Rosa, California, United States
Univ. Colorado at Denver, Aurora, Colorado, United States
Connecticut Oncology & Hematology, Torrington, Connecticut, United States
Medical Oncology Hematology, Waterbury, Connecticut, United States
Florida Oncology Associates, Jacksonville, Florida, United States
Hematology Oncology Associates, Port St. Lucie, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Northeast Georgia Cancer Care, Athens, Georgia, United States
Peachtree Hematology Oncology, Atlanta, Georgia, United States
Emory University, Atlanta, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Central Georgia Cancer Care, Macon, Georgia, United States
Summit Cancer Care, Savannah, Georgia, United States
Kootenai Medical Center, Post Falls, Idaho, United States
Ingalls Memorial Hospital, Chicago, Illinois, United States
Rush University, Chicago, Illinois, United States
Mid Illinois Hematology & Oncology, Normal, Illinois, United States
Cancer Treatment Centers of America, Zion, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Community Hospitals of Indiana, Indianapolis, Indiana, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Montgomery Cancer Care, Mount Sterling, Kentucky, United States
Michigan State University, East Lansing, Michigan, United States
New Mexico Cancer Center, Albuquerque, New Mexico, United States
Prohealth Associates, Lake Success, New York, United States
Stony Brook University, Stony Brook, New York, United States
Carolinas Hematology/Oncology, Charlotte, North Carolina, United States
Moses Cone Medical System, Greensboro, North Carolina, United States
Case Western Reserve Univ., Cleveland, Ohio, United States
Mercy Physicians of Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Kaiser Northwest, Portland, Oregon, United States
Pinnacle Health, Harrisburg, Pennsylvania, United States
Penn. State Univ., Hershey, Pennsylvania, United States
The Jones Clinic, Germantown, Tennessee, United States
The West Clinic, Memphis, Tennessee, United States
Scott & White Healthcare, Temple, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Medical Oncology Associates, Spokane, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
Stronach Regional Cancer Centre at Southlake, Newmarket, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Health Services Centre, Toronto, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Name: Ted Shih, PharmD
Affiliation: Geron Corporation
Role: STUDY_DIRECTOR
Name: Kathy Miller, MD
Affiliation: Indiana University School of Medicine
Role: PRINCIPAL_INVESTIGATOR