Breast Cancer Clinical Trial
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
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.
Full 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 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 neoadjuvant TC chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
Platelet count ≥ 100×10^9/L
Hemoglobin > 9 g/dL
Creatinine clearance > 50 mL/min
Total bilirubin ≤ 1.5 mg/dL
Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).
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 or metastatic breast cancer
Known sensitivity to E. coli -derived products or to any products to be administered during dosing
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 serious underlying medical condition that would impair ability to receive protocol treatment
Prior bone marrow or stem cell transplant
Use of 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 81 Locations for this study
Glendale Arizona, 85306, United States
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
Bakersfield California, 93309, United States
Berkeley California, 94704, United States
Chula Vista California, 91910, United States
Corona California, 92879, United States
Fountain Valley California, 92708, United States
Long Beach California, 90806, United States
Long Beach California, 90813, United States
Oxnard California, 93030, United States
Pleasanton California, 94588, United States
Redlands California, 92373, United States
Riverside California, 92501, United States
Santa Rosa California, 95403, United States
West Hills California, 91307, United States
Whittier California, 90603, United States
DeBary Florida, 32713, United States
Holiday Florida, 34691, United States
Miami Lakes Florida, 33014, United States
Miami Florida, 33133, United States
Orange City Florida, 32763, United States
Plantation Florida, 33324, United States
Winter Haven Florida, 33881, United States
Columbus Georgia, 31904, United States
Fort Gordon Georgia, 30905, United States
Savannah Georgia, 31404, United States
Boise Idaho, 83706, United States
Chicago Illinois, 60625, United States
Joliet Illinois, 60435, United States
Park Ridge Illinois, 60068, United States
Rockford Illinois, 61114, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46237, United States
New Albany Indiana, 47150, United States
Westville Indiana, 46391, United States
Ashland Kentucky, 41101, United States
Paducah Kentucky, 42003, United States
Covington Louisiana, 70433, United States
Shreveport Louisiana, 71105, United States
Rockport Maine, 04856, United States
Bethesda Maryland, 20817, United States
Worcester Massachusetts, 01608, United States
Royal Oak Michigan, 48073, United States
Hattiesburg Mississippi, 39401, United States
Joplin Missouri, 64804, United States
Billings Montana, 59102, United States
Grand Island Nebraska, 68803, United States
Lincoln Nebraska, 68510, United States
Brick New Jersey, 08724, United States
East Setauket New York, 11733, United States
Cary North Carolina, 27518, United States
Canton Ohio, 44710, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45219, United States
Youngstown Ohio, 44504, United States
Corvallis Oregon, 97330, United States
Pittsburgh Pennsylvania, 15232, United States
Upland Pennsylvania, 19013, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29607, United States
Rock Hill South Carolina, 29732, United States
Cookeville Tennessee, 38501, United States
Germantown Tennessee, 38138, United States
Bryan Texas, 77802, United States
Dallas Texas, 75203, United States
Houston Texas, 77030, United States
McAllen Texas, 78503, United States
Richardson Texas, 75082, United States
Ogden Utah, 84403, United States
Portsmouth Virginia, 23704, United States
Tacoma Washington, 98405, United States
Morgantown West Virginia, 26506, United States
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Québec Quebec, G1S 4, Canada
Seongnam-si Gyeonggi-do, 13496, Korea, Republic of
Sinchon-dong Seoul, 03722, Korea, Republic of
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