Trial Outcomes & Findings for Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer (NCT NCT01724866)

Results Overview

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

Cycle 1 (each cycle was 21 days)

Results posted on

2022-04-15

Participant Flow

Participants were enrolled at 27 investigative sites in the United States (10 sites), Australia (5 sites), Georgia (2 sites), Hungary (5 sites), Israel (1 site), and Poland (4 sites) from 25 March 2013 to 12 August 2014.

A total of 148 participants were randomized in the study, out of which 138 participants completed the study.

Participant milestones

Participant milestones
Measure	Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) Participants received SPI-2012 45 µg/kg, subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Overall Study STARTED	39	37	36	36
Overall Study Evaluable Population	39	36	36	36
Overall Study COMPLETED	38	32	33	35
Overall Study NOT COMPLETED	1	5	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) Participants received SPI-2012 45 µg/kg, subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Overall Study Adverse Event	0	0	1	1
Overall Study Initiation of Non-Protocol Therapy Either for Progressive Disease or Intolerance of TC Regimen	0	2	0	0
Overall Study Investigator's Discretion	0	1	1	0
Overall Study Need for Chemotherapy or Chemotherapy Regimen was Changed due to Amended HER2 Status	1	0	0	0
Overall Study Participant Refused Further Treatment or Withdrew Consent	0	2	1	0

Baseline Characteristics

Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Total n=147 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 11.31 • n=5 Participants	56.8 years STANDARD_DEVIATION 10.63 • n=7 Participants	55.7 years STANDARD_DEVIATION 9.79 • n=5 Participants	60.4 years STANDARD_DEVIATION 10.43 • n=4 Participants	58.2 years STANDARD_DEVIATION 10.64 • n=21 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	35 Participants n=7 Participants	34 Participants n=5 Participants	36 Participants n=4 Participants	144 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	32 Participants n=4 Participants	133 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	36 Participants n=5 Participants	36 Participants n=7 Participants	35 Participants n=5 Participants	32 Participants n=4 Participants	139 Participants n=21 Participants
Race/Ethnicity, Customized Others	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Cycle 1 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Duration of Severe Neutropenia (DSN) in Cycle 1	1.03 days Standard Deviation 1.547	0.44 days Standard Deviation 1.275	0.03 days Standard Deviation 0.167	0.31 days Standard Deviation 0.822

SECONDARY outcome

Timeframe: Cycle 2 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 2.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=34 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Duration of DSN in Cycle 2	0.46 days Standard Deviation 1.022	0.12 days Standard Deviation 0.478	0.03 days Standard Deviation 0.171	0.08 days Standard Deviation 0.368

SECONDARY outcome

Timeframe: Cycle 3 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 3.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Duration of DSN in Cycle 3	0.45 days Standard Deviation 1.132	0.16 days Standard Deviation 0.628	0.15 days Standard Deviation 0.610	0.14 days Standard Deviation 0.593

SECONDARY outcome

Timeframe: Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 4.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=33 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=35 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Duration of DSN in Cycle 4	1.05 days Standard Deviation 4.579	0.19 days Standard Deviation 0.738	0.09 days Standard Deviation 0.522	0.11 days Standard Deviation 0.404

SECONDARY outcome

Timeframe: Cycle 1 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 1.

Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=29 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=14 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=6 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=14 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Recovery in Cycle 1	10.0 days Interval 10.0 to 11.0	8.5 days Interval 8.0 to 9.0	8.0 days Interval 7.0 to 9.0	9.0 days Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: Cycle 2 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 2.

Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 2.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=23 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=8 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=7 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=10 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Recovery in Cycle 2	11.0 days Interval 10.0 to 11.0	9.5 days Interval 8.0 to 10.0	10.0 days Interval 8.0 to 14.0	10.0 days Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: Cycle 3 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 3.

Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 3.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=20 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=6 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=5 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=9 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Recovery in Cycle 3	10.0 days Interval 10.0 to 11.0	9.5 days Interval 8.0 to 12.0	9.0 days Interval 8.0 to 13.0	10.0 days Interval 9.0 to 11.0

SECONDARY outcome

Timeframe: Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 4.

Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 4.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=23 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=8 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=4 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=12 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Recovery in Cycle 4	11.0 days Interval 10.0 to 13.0	10.0 days Interval 9.0 to 11.0	10.0 days Interval 8.0 to 14.0	10.0 days Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: Cycle 1 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1	1.5 10^9 ANC per liter Standard Deviation 1.77	4.0 10^9 ANC per liter Standard Deviation 3.86	7.2 10^9 ANC per liter Standard Deviation 5.47	3.2 10^9 ANC per liter Standard Deviation 2.43

SECONDARY outcome

Timeframe: Cycle 2 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=34 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Absolute ANC Nadir Overtime in Cycle 2	2.0 10^9 ANC/L Standard Deviation 1.89	3.9 10^9 ANC/L Standard Deviation 2.55	6.8 10^9 ANC/L Standard Deviation 6.30	3.3 10^9 ANC/L Standard Deviation 2.16

SECONDARY outcome

Timeframe: Cycle 3 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Absolute ANC Nadir Overtime in Cycle 3	2.3 10^9 ANC/L Standard Deviation 1.87	4.4 10^9 ANC/L Standard Deviation 3.26	6.1 10^9 ANC/L Standard Deviation 4.81	3.5 10^9 ANC/L Standard Deviation 1.92

SECONDARY outcome

Timeframe: Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=33 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=35 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Absolute ANC Nadir Overtime in Cycle 4	2.1 10^9 ANC/L Standard Deviation 2.12	4.1 10^9 ANC/L Standard Deviation 2.86	4.8 10^9 ANC/L Standard Deviation 3.00	2.7 10^9 ANC/L Standard Deviation 1.64

SECONDARY outcome

Timeframe: Cycle 1 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Depth of ANC Nadir in Cycle 1	0.8 10^9 ANC/L Interval 0.0 to 9.0	3.0 10^9 ANC/L Interval 0.1 to 14.1	6.2 10^9 ANC/L Interval 0.2 to 21.0	3.0 10^9 ANC/L Interval 0.0 to 9.1

SECONDARY outcome

Timeframe: Cycle 2 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=34 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Depth of ANC Nadir in Cycle 2	1.3 10^9 ANC/L Interval 0.1 to 8.0	3.3 10^9 ANC/L Interval 0.1 to 9.5	4.8 10^9 ANC/L Interval 0.3 to 25.7	2.9 10^9 ANC/L Interval 0.1 to 9.2

SECONDARY outcome

Timeframe: Cycle 3 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Depth of ANC Nadir in Cycle 3	1.9 10^9 ANC/L Interval 0.0 to 7.3	3.4 10^9 ANC/L Interval 0.1 to 12.3	4.1 10^9 ANC/L Interval 0.2 to 21.4	3.5 10^9 ANC/L Interval 0.1 to 8.1

SECONDARY outcome

Timeframe: Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=33 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=35 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Depth of ANC Nadir in Cycle 4	8.0 10^9 ANC/L Interval 0.0 to 9.2	4.2 10^9 ANC/L Interval 0.1 to 11.2	4.2 10^9 ANC/L Interval 0.4 to 11.9	2.4 10^9 ANC/L Interval 0.1 to 6.4

SECONDARY outcome

Timeframe: Cycle 1 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Nadir in Cycle 1	8.0 Days Interval 7.0 to 8.0	7.0 Days Interval 7.0 to The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.	7.0 Days Interval 7.0 to 8.0	7.5 Days Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: Cycle 2 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=34 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Nadir in Cycle 2	8.0 days Interval 8.0 to The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.	7.0 days Interval 7.0 to 8.0	8.0 days Interval 7.0 to 10.0	8.0 days Interval 7.0 to 15.0

SECONDARY outcome

Timeframe: Cycle 3 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=34 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Nadir in Cycle 3	8.0 days Interval 8.0 to The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.	7.0 days Interval 7.0 to 8.0	8.0 days Interval 7.0 to 9.0	8.0 days Interval 7.0 to 15.0

SECONDARY outcome

Timeframe: Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=38 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=32 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=33 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=35 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to ANC Nadir in Cycle 4	8.0 days Interval 8.0 to The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.	8.0 days Interval 7.0 to 8.0	8.0 days Interval 7.0 to 21.0	8.0 days Interval 7.0 to 8.0

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10\^9/L..

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4	7.7 percentage of participants	2.8 percentage of participants	2.8 percentage of participants	5.6 percentage of participants

SECONDARY outcome

Timeframe: From the first dose up to 30 days post last dose of study drug (up to 4 months)

Population: The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities ("Hematology and Chemistry") were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=37 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities Grade 3-4 TEAEs	24 Participants	12 Participants	13 Participants	12 Participants
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities Death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities SAEs Other Than Death	5 Participants	4 Participants	2 Participants	8 Participants
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities TEAEs Leading to Discontinuation From Study Therapy	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities Grade 3-4 Lab Abnormalities: Hematology	33 Participants	19 Participants	18 Participants	28 Participants
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities Grade 3-4 Lab Abnormalities: Chemistry	8 Participants	4 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=36 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 Participants Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4	7.7 percentage of participants	8.3 percentage of participants	2.8 percentage of participants	13.9 percentage of participants

SECONDARY outcome

Timeframe: Up to the end of the study (Approximately 3.5 months)

Population: The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed included participants who were treated with SPI-2012 and had post-treatment samples collected, and excluded participants who tested positive before being treated with SPI-2012. Data was collected and analyzed only for the "SPI-2012" reporting arms as per the planned analysis.

Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=35 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=35 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=30 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Number of Participants With Positive Antibodies for SPI-2012	0 Participants	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

Population: The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and have sufficient number of blood samples. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=2 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=4 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=3 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Time to Reach Maximum Concentration of SPI-2012 (Tmax)	58.7 hours (hrs) Interval 46.9 to 70.5	9.00 hours (hrs) Interval 8.0 to 48.1	24.0 hours (hrs) Interval 24.0 to 24.1	—

SECONDARY outcome

Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

Population: The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and had sufficient number of blood samples. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=3 Participants Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=4 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=3 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Maximum Concentration of SPI-2012 (Cmax)	7.00 nanograms per milliliter (ng/mL) Standard Deviation 6.08	247 nanograms per milliliter (ng/mL) Standard Deviation 276	299 nanograms per milliliter (ng/mL) Standard Deviation 329	—

SECONDARY outcome

Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

Population: The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and have sufficient number of blood samples to estimate AUC. The AUC0-312 was not calculated for the 45 µg/kg dose due to insufficient data in the serum concentration profiles. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=2 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=3 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)	—	16000 nanogramhour per milliliter (nghr/mL) Standard Deviation 5850	22900 nanogramhour per milliliter (nghr/mL) Standard Deviation 25100	—

SECONDARY outcome

Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)

Population: The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and had sufficient number of blood samples to estimate AUC. The t1/2 was not calculated for the 45 µg/kg arm because there were insufficient data in terminal phase of serum concentration profiles. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

t1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.

Outcome measures

Outcome measures
Measure	Arm 1: SPI-2012 45 µg/kg and TC Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=2 Participants Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=1 Participants Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Half-life of SPI-2012 (t1/2)	—	81.0 hrs Standard Deviation 88.4	31.5 hrs Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	—

Adverse Events

Arm 1: SPI-2012 45 µg/kg and TC

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Arm 2: SPI-2012 135 µg/kg and TC

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm 3: SPI-2012 270 µg/kg and TC

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm 4: Pegfilgrastim and TC

Serious events: 8 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm 1: SPI-2012 45 µg/kg and TC n=39 participants at risk Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 2: SPI-2012 135 µg/kg and TC n=37 participants at risk Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 3: SPI-2012 270 µg/kg and TC n=36 participants at risk Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.	Arm 4: Pegfilgrastim and TC n=36 participants at risk Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.
Gastrointestinal disorders Diarrhoea	43.6% 17/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	18.9% 7/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	38.9% 14/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	41.7% 15/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Gastrointestinal disorders Nausea	48.7% 19/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	32.4% 12/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	41.7% 15/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	44.4% 16/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
General disorders Asthenia	12.8% 5/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	5.4% 2/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	13.9% 5/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	22.2% 8/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
General disorders Fatigue	61.5% 24/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	29.7% 11/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	52.8% 19/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	55.6% 20/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Musculoskeletal and connective tissue disorders Bone pain	23.1% 9/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	27.0% 10/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	33.3% 12/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	36.1% 13/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Nervous system disorders Headache	30.8% 12/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	13.5% 5/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	22.2% 8/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	25.0% 9/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Skin and subcutaneous tissue disorders Alopecia	53.8% 21/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	48.6% 18/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	33.3% 12/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	36.1% 13/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Psychiatric disorders Insomnia	7.7% 3/39 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	13.5% 5/37 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	13.9% 5/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).	30.6% 11/36 • From the first dose up to 30 days post last dose of study drug (up to 4 months) The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).

Additional Information

Shanta Chawla

Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

Phone: (949) 788-6700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place