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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Single-dose subcutaneous injection administered on Day 2 of each cycle
Standard therapy
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/L), after the administration of study drug in Cycle 1.
Time frame: Day 1 and Days 4-15 in Cycle 1 (each cycle was 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 ANC increased to ≥1.5×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\^9/L.
Time frame: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1
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 Days 4, 15 in Cycle 1 (each cycle was 21 days)
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN was defined as an oral temperature \> 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L.
Time frame: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
Duration of Severe Neutropenia in Cycle 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 an ANC below the threshold in Cycles 2, 3, and 4.
Time frame: Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)
Number of Participants With Neutropenic Complications in Cycle 1
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Standard therapy
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
...and 71 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 Days 4, 15 in Cycle 1 (each cycle was 21 days)
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4
FN was defined as an oral temperature \> 38.3 degrees C (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees 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 was 21 days)
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4
RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and 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 to 4 (each cycle was 21 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. 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: From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)