Breast Cancer Clinical Trial
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
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).
Full 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 Criteria
Key Inclusion Criteria:
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
Candidate for adjuvant or neo-adjuvant TC chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Absolute neutrophil count (ANC) >=1.5×10^9/L
Platelet count >=100×10^9/L
Hemoglobin >9 g/dL
Calculated creatinine clearance > 50 mL/min
Total bilirubin <=1.5 mg/dL
Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
Alkaline phosphatase <=2.0×ULN
Key Exclusion Criteria:
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
Locally recurrent/metastatic breast cancer
Known sensitivity to E. coli-derived products
Concurrent adjuvant cancer therapy
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
Prior bone marrow or stem cell transplant
Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
Major surgery within 30 days prior to enrollment
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There are 74 Locations for this study
Tucson Arizona, 85715, United States
Yuma Arizona, 85364, United States
Hot Springs Arkansas, 71913, United States
Jonesboro Arkansas, 72401, United States
Anaheim California, 92801, United States
Fountain Valley California, 92708, United States
Fresno California, 93720, United States
Long Beach California, 90813, United States
Los Angeles California, 90017, United States
Palm Springs California, 92262, United States
Redlands California, 92373, United States
Whittier California, 90603, United States
Denver Colorado, 80204, United States
Holiday Florida, 34691, United States
Miami Lakes Florida, 33014, United States
Orange City Florida, 32763, United States
Pembroke Pines Florida, 33024, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33709, United States
Winter Haven Florida, 33880, United States
Columbus Georgia, 31904, United States
Dublin Georgia, 31021, United States
Fort Gordon Georgia, 30905, United States
Boise Idaho, 83706, United States
Park Ridge Illinois, 60068, United States
Indianapolis Indiana, 46237, United States
Danville Kentucky, 40422, United States
Covington Louisiana, 70433, United States
Royal Oak Michigan, 48073, United States
Saint Cloud Minnesota, 56303, United States
Hattiesburg Mississippi, 39401, United States
Joplin Missouri, 64804, United States
Billings Montana, 59102, United States
Grand Island Nebraska, 68803, United States
Cary North Carolina, 27518, United States
Gastonia North Carolina, 28054, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45219, United States
Youngstown Ohio, 44501, United States
Rock Hill South Carolina, 29732, United States
Germantown Tennessee, 38138, United States
Bryan Texas, 77802, United States
Laredo Texas, 78041, United States
McAllen Texas, 78503, United States
Tyler Texas, 75701, United States
Portsmouth Virginia, 23704, United States
Everett Washington, 98201, United States
Tacoma Washington, 98405, United States
Morgantown West Virginia, 26506, United States
Longueuil Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Budapest , 1062, Hungary
Budapest , 1115, Hungary
Budapest , 1122, Hungary
Miskolc , 3526, Hungary
NyÃregyháza , 4400, Hungary
Szekszard , 7100, Hungary
Pune Maharashtra, 41101, India
Vellore Tamil Nadu, 63200, India
Irwon-ro Gangnam-gu Seoul, 06351, Korea, Republic of
Ilsan-ro Gangwon-do, 26426, Korea, Republic of
IIsan-ro Gyeonggi-do, 10408, Korea, Republic of
Yatap-ro Gyeonggi-do, 13496, Korea, Republic of
Daehwa-ro Jongno-gu Seoul, 03080, Korea, Republic of
Inhang-ro Jung-guIncheon, 22332, Korea, Republic of
Inchon-ro Seongbuk-guSeoul, 02841, Korea, Republic of
Yonsei-ro Seoul, 03722, Korea, Republic of
Bialystok , 15-02, Poland
Grudziadz , 86-30, Poland
Lodz , 93-33, Poland
Poznan , 60-56, Poland
Racibórz , 47-40, Poland
Rzeszow , 35-02, Poland
Szczecin , 71-73, Poland
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