Spots Global Cancer Trial Database for SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
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Trial Identification
Brief Title: SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
Official Title: RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)
Study ID: NCT02643420
Study Description
Brief Summary: The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.
Detailed Description: This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy. Each cycle was 21 days. Four cycles were evaluated in this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Center for Cancer Care, Glendale, Arizona, United States
Arizona Clinical Research Center/ ACRC, Tucson, Arizona, United States
Yuma Regional Medical Center, Yuma, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
NEA Baptist Clinic | Fowler Family Center for Cancer Care, Jonesboro, Arkansas, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Alta Bates Summit Medical Center, Berkeley, California, United States
Precision Research Institute, LLC, Chula Vista, California, United States
Compassionate Cancer Care Medical Group, Inc., Corona, California, United States
Compassionate Care Research Group, Inc., Fountain Valley, California, United States
Long Beach Memorial Medical Center, Long Beach, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
Valley Medical Oncology Consultants, Pleasanton, California, United States
Emad Ibrahim, MD, Inc., Redlands, California, United States
Compassionate Cancer Care Medical Group, Inc, Riverside, California, United States
St Joseph Heritage Healthcare Institution, Santa Rosa, California, United States
Wellness Oncology Hematology, West Hills, California, United States
Oncology Institute of Hope and Innovation, Whittier, California, United States
Omega Research Consultants LLC, DeBary, Florida, United States
Pasco Pinellas Cancer Center, Holiday, Florida, United States
Lakes Research, LLC, Miami Lakes, Florida, United States
AMPM Research Clinic, Miami, Florida, United States
Mid Florida Hematology and Oncology Centers, Orange City, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
Bond Clinic, P.A., Winter Haven, Florida, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Clintell, Inc/Swedish Covenant Hospital, Chicago, Illinois, United States
Joliet Oncology Hematology Associates, Joliet, Illinois, United States
Oncology Specialists, SC, Park Ridge, Illinois, United States
Swedish American Cancer Center, Rockford, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
Floyd Memorial Cancer Center of Indiana, New Albany, Indiana, United States
Northern Indiana Cancer Research Consortium, Westville, Indiana, United States
Ashland-Bellefonte Cancer Center, Ashland, Kentucky, United States
West Ky Hematology & Oncology Group, PSC, Paducah, Kentucky, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
Highland Clinic, Shreveport, Louisiana, United States
Penobscot Bay Medical Center, Rockport, Maine, United States
RCCA MD LLC/The Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Reliant Medical Group, Worcester, Massachusetts, United States
Quest Research Institute, Royal Oak, Michigan, United States
Forrest General Hospital, Hattiesburg, Mississippi, United States
Freeman Health Systems, Joplin, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Saint Francis Cancer Treatment Center, Grand Island, Nebraska, United States
Southeast Nebraska Hematology & Oncology Consultants, PC, Lincoln, Nebraska, United States
New Jersey Hematology Oncology Associates, Brick, New Jersey, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Waverly Hematology Oncology, Cary, North Carolina, United States
Aultman Hospital, Canton, Ohio, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
The Lindner Research Center at the Christ Hospital, Cincinnati, Ohio, United States
Mercy Health Youngstown LLC DBA, Youngstown, Ohio, United States
Good Samaritan Hospital Corvallis, Corvallis, Oregon, United States
University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States
Associates in Hematology and Oncology, PC, Upland, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Bon Secours Saint Francis Cancer, Greenville, South Carolina, United States
Carolina Blood and Cancer Care, Rock Hill, South Carolina, United States
Cookeville Regional Medical Center, Cookeville, Tennessee, United States
The West Clinic, PC, d/b/a West Cancer Center, Germantown, Tennessee, United States
CHI St. Joseph Health Cancer Center, Bryan, Texas, United States
Texas Oncology -Methodist Dallas Cancer Center, Dallas, Texas, United States
Oncology Consultants, Houston, Texas, United States
Texas Oncology, PA, McAllen, Texas, United States
Methodist Richardson Medical Center- Cancer Center, Richardson, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Delta Oncology Associates, Portsmouth, Virginia, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
CISSS de la Montérégie-Centre, Greenfield Park, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHU de Quebec - Universite Laval, Québec, Quebec, Canada
Cha Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital, Sinchon-dong, Seoul, Korea, Republic of
Contact Details
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