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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
237
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Subcutaneous injection administered on Day 2 of each cycle.
75mg/m\^2 IV infusion administered on Day 1 of each cycle
Duration of Severe Neutropenia (DSN) in Cycle 1
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to \>=1.5×10\^9/L after the expected nadir. For participants with ANC value \>=1.5×10\^9/L at all times, time to ANC Recovery was assigned a value of 0.
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Depth of ANC Nadir in Cycle 1
The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9/L) from the first occurrence of ANC below the threshold.
Time frame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
Number of Participants With Neutropenic Complications in Cycle 1
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600mg/m\^2 IV infusion administered on Day 1 of each cycle
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
...and 64 more locations
Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
Time frame: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
Relative Dose Intensity (RDI) of TC Chemotherapy
RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.
Time frame: Cycles 1, 2, 3 and 4 (each cycle = 21 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.
Time frame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
Number of Participants With Clinically Significant Laboratory Abnormalities
The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.
Time frame: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)