Spots Global Cancer Trial Database for SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
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Trial Identification
Brief Title: SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
Official Title: Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
Study ID: NCT02953340
Study Description
Brief Summary: The purpose of this study is to compare the efficacy 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).
Detailed Description: This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN). Each cycle was 21 days. Four cycles were evaluated for 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). After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ACRC/ Arizona Clinical Research Center Inc., Tucson, Arizona, United States
Yuma Regional Cancer 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
Compassionate Care Research Group, Inc., Fountain Valley, California, United States
California Cancer Associates for Research and Excellence Inc., Fresno, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
Desert Regional Medical Center, Palm Springs, California, United States
Emad Ibrahim, MD, INC., Redlands, California, United States
Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation, Whittier, California, United States
Denver Health & Hospital Authority, Denver, Colorado, United States
Pasco Pinellas Cancer Center, Holiday, Florida, United States
Lakes Research, LLC, Miami Lakes, Florida, United States
Mid-Florida Hematology and Oncology Centers, Orange City, Florida, United States
Millennium Oncology, Pembroke Pines, Florida, United States
BRCR Medical Center Inc, Plantation, Florida, United States
Pinellas Hematology and Oncology, Saint Petersburg, Florida, United States
Bond & Steele Clinic, PA., Winter Haven, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Cancer Center of Middle Georgia, Dublin, Georgia, United States
Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Oncology Specialists, SC, Park Ridge, Illinois, United States
FPN Oncology and Hematology Specialists, Indianapolis, Indiana, United States
Commonwealth Hematology-Oncology, PSC, Danville, Kentucky, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
Quest Research Institute, Royal Oak, Michigan, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology, Hattiesburg, Mississippi, United States
Freeman Health Systems, Joplin, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
CHI Health St Francis, St Francis Cancer Treatment Center, Grand Island, Nebraska, United States
Waverly Hematology Oncology, Cary, North Carolina, United States
Gaston Hematology & Oncology Associates, PC, Gastonia, North Carolina, United States
Aultman Hospital, Canton, Ohio, United States
The Christ Hospital Cancer Center, Cincinnati, Ohio, United States
St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC, Youngstown, Ohio, United States
Carolina Blood and Cancer Care Associates, Rock Hill, South Carolina, 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
Envision Cancer Center, LLC, Laredo, Texas, United States
Texas Oncology, PA- McAllen South 2nd Street, McAllen, Texas, United States
HOPE Cancer Center of East Texas, Tyler, Texas, United States
Delta Hematology/Oncology Associates, Portsmouth, Virginia, United States
Providence Regional Center Partnership, Everett, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
CISSS de la Montérégie-Centre, Longueuil, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly, Budapest, , Hungary
Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly, Budapest, , Hungary
Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly, Budapest, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum, Miskolc, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly, Nyíregyháza, , Hungary
Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly, Szekszard, , Hungary
KEM Hospital Research Centre, Pune, Maharashtra, India
Christian Medical College, Vellore, Tamil Nadu, India
Samsung Medical Center, Irwon-ro, Gangnam-gu Seoul, Korea, Republic of
Wonju Severance Christian Hospital, Ilsan-ro, Gangwon-do, Korea, Republic of
National Cancer Center, IIsan-ro, Gyeonggi-do, Korea, Republic of
Cha Bundang Medical Center, Yatap-ro, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Daehwa-ro, Jongno-gu Seoul, Korea, Republic of
Inha University Hospital, Inhang-ro, Jung-guIncheon, Korea, Republic of
Korea University Anam Hospital, Inchon-ro, Seongbuk-guSeoul, Korea, Republic of
Severance Hospital, Yonsei-ro, Seoul, Korea, Republic of
BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej, Bialystok, , Poland
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej, Grudziadz, , Poland
Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej, Lodz, , Poland
Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu, Poznan, , Poland
Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii, Racibórz, , Poland
MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszow, , Poland
Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin, , Poland
Contact Details
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