Spots Global Cancer Trial Database for Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
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Trial Identification
Brief Title: Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
Official Title: An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
Study ID: NCT00050011
Study Description
Brief Summary: This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Highlands Oncology Group, Springdale, Arkansas, United States
East Valley Hematology & Oncology, Burbank, California, United States
Louisiana Oncology Associates, Lafayette, California, United States
Wilshire Oncology Medical Group, LaVerne, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Clinical Trials & Research Associates, Inc., Montebello, California, United States
Redwood Regional Medical Group, Santa Rosa, California, United States
Cancer and Blood Institute of the Desert, Rancho Mirage, Colorado, United States
Eastern Connecticut Hematology/Oncology Associates, Norwich, Connecticut, United States
FL Community Cancer Center, Brooksville, Florida, United States
Robert R. Carroll, MD, PA, Gainesville, Florida, United States
Oncology Hematology Group of South Florida, Miami, Florida, United States
Pasco Pinellas Cancer Center, New Port Richey, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Cancer Research Network, Inc., Plantation, Florida, United States
Bay Area Oncology, Tampa, Florida, United States
Space Coast Medical, Titusville, Florida, United States
Elmhurst Memorial Hospital, Elhurst, Illinois, United States
Kentuckiana Cancer Institute, Louisville, Kentucky, United States
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland, United States
New England Hematology/Oncology Associates, Wellesley, Massachusetts, United States
Cook Research Department at Spectrum Health, Grand Rapids, Michigan, United States
Metro Minnesota CCOP, St. Louis Park, Minnesota, United States
Hematology-Oncology Centers of the Northern Rockies, PC, Billings, Montana, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey, United States
New Mexico Oncology Hematology, Ltd., Albuquerque, New Mexico, United States
Hemoncare PC, Brooklyn, New York, United States
Odyssey Research Services, Bismarck, North Dakota, United States
Nashat Y. Gabrail MD Inc., Canton, Ohio, United States
Oncology Partners Network, Cincinnati, Ohio, United States
Physician Associates, Inc., Cincinnati, Ohio, United States
Dayton Clinical Oncology Program, Dayton, Ohio, United States
University of Pittsburgh Cancer Institute/Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology, Charleston, South Carolina, United States
The Sarah Cannon Cancer Center, Nashville, Tennessee, United States
St. Joseph Regional Cancer Center, Bryan, Texas, United States
Cancer Specialists of South Texas, Corpus Christi, Texas, United States
Center for Oncology Research & Tx. PA, Dallas, Texas, United States
Northern Virginia Oncology Group, Fairfax, Virginia, United States
Virginia Physicians, Inc.- Oncology, Richmond, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Rockwood Clinic, PS, Spokane, Washington, United States
VA Medical Center, San Juan, , Puerto Rico
Contact Details
Name: Novartis Pharmaceuticals, MD
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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