Trial · NCT02953340
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
NCT02953340, Phase 3, Completed, Spectrum Pharmaceuticals, Inc; results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide. Trials, record NCT02953340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02953340
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
- NCT number
- NCT02953340
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 237 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Neutropenia, Breast Cancer
- Interventions
- SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
- First posted
- 2016-11-02
- Last updated
- 2022-03-02
- Other registries' IDs
- eudract:2016-003469-24
- Results first posted
- 2022-03-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Severe Neutropenia (DSN) in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold. |
| Secondary | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to \>=1.5×10\^9/L after the expected nadir. For participants with ANC value \>=1.5×10\^9/L at all times, time to ANC Recovery was assigned a value of 0. |
| Secondary | Depth of ANC Nadir in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1. |
| Secondary | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L. |
| Secondary | Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 | Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) | DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9/L) from the first occurrence of ANC below the threshold. |
| Secondary | Number of Participants With Neutropenic Complications in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia. |
| Secondary | Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4 | Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) | FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L. |
| Secondary | Relative Dose Intensity (RDI) of TC Chemotherapy | Cycles 1, 2, 3 and 4 (each cycle = 21 days) | RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death | Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) | An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) | The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Severe Neutropenia (DSN) in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | ITT population included all participants who were randomized. | Days | MEAN |
| SECONDARY | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | ITT population included all participants who were randomized. | Days | MEAN |
| SECONDARY | Depth of ANC Nadir in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure at the specified timepoint. | 10^9 cells/L | MEAN |
| SECONDARY | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | ITT population included all participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 | Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) | ITT population included all participants who were randomized. | Days | MEAN |
| SECONDARY | Number of Participants With Neutropenic Complications in Cycle 1 | Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days) | ITT population included all participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4 | Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days) | ITT population included all participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relative Dose Intensity (RDI) of TC Chemotherapy | Cycles 1, 2, 3 and 4 (each cycle = 21 days) | Safety analysis (SAF) population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). | Percentage of planned dose | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death | Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) | SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months) | SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Severe Neutropenia (DSN) in Cycle 1 | (Arm 1): SPI-2012 and TC | 0.31 | Standard Deviation 0.688 | Days | |
| Duration of Severe Neutropenia (DSN) in Cycle 1 | (Arm 2): Pegfilgrastim and TC | 0.39 | Standard Deviation 0.949 | Days | |
| Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | (Arm 1): SPI-2012 and TC | 3.49 | Standard Deviation 3.723 | Days | |
| Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | (Arm 2): Pegfilgrastim and TC | 3.35 | Standard Deviation 3.745 | Days | |
| Depth of ANC Nadir in Cycle 1 | (Arm 1): SPI-2012 and TC | 2.67 | Standard Deviation 3.504 | 10^9 cells/L | |
| Depth of ANC Nadir in Cycle 1 | (Arm 2): Pegfilgrastim and TC | 2.06 | Standard Deviation 2.034 | 10^9 cells/L | |
| Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | (Arm 1): SPI-2012 and TC | 1 | Participants | ||
| Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | (Arm 2): Pegfilgrastim and TC | 4 | Participants | ||
| Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 | (Arm 1): SPI-2012 and TC | Cycle 2 | 0.08 | Standard Deviation 0.267 | Days |
| Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 | (Arm 2): Pegfilgrastim and TC | Cycle 2 | 0.09 | Standard Deviation 0.432 | Days |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | (Arm 1): SPI-2012 and TC | 118 | |
| Overall Study | STARTED | (Arm 2): Pegfilgrastim and TC | 119 | |
| Overall Study | Safety Population | (Arm 1): SPI-2012 and TC | 117 | |
| Overall Study | Safety Population | (Arm 2): Pegfilgrastim and TC | 118 | |
| Overall Study | Entered Safety Follow-up Period | (Arm 1): SPI-2012 and TC | 117 | |
| Overall Study | Entered Safety Follow-up Period | (Arm 2): Pegfilgrastim and TC | 118 | |
| Overall Study | COMPLETED | (Arm 1): SPI-2012 and TC | 96 | |
| Overall Study | COMPLETED | (Arm 2): Pegfilgrastim and TC | 85 | |
| Overall Study | NOT COMPLETED | (Arm 1): SPI-2012 and TC | 22 | |
| Overall Study | NOT COMPLETED | (Arm 2): Pegfilgrastim and TC | 34 |
Source ClinicalTrials.gov
Adverse events400
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Flushing | Vascular disorders | (Arm 1): SPI-2012 and TC | 9 | 117 | |
| other | Flushing | Vascular disorders | (Arm 2): Pegfilgrastim and TC | 10 | 118 | |
| other | Flushing | Vascular disorders | (Arm 1): SPI-2012 and TC: Follow-up Period | 0 | 117 | |
| other | Flushing | Vascular disorders | (Arm 2): Pegfilgrastim and TC: Follow-up Period | 2 | 118 | |
| other | Hot flush | Vascular disorders | (Arm 1): SPI-2012 and TC | 10 | 117 | |
| other | Hot flush | Vascular disorders | (Arm 2): Pegfilgrastim and TC | 8 | 118 | |
| other | Hot flush | Vascular disorders | (Arm 1): SPI-2012 and TC: Follow-up Period | 1 | 117 | |
| other | Hot flush | Vascular disorders | (Arm 2): Pegfilgrastim and TC: Follow-up Period | 3 | 118 | |
| other | Hypertension | Vascular disorders | (Arm 1): SPI-2012 and TC | 4 | 117 | |
| other | Hypertension | Vascular disorders | (Arm 2): Pegfilgrastim and TC | 8 | 118 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (Arm 1): SPI-2012 and TC | 0 | 117 |
| Total, all-cause mortality | (Arm 2): Pegfilgrastim and TC | 1 | 118 |
| Total, all-cause mortality | (Arm 1): SPI-2012 and TC: Follow-up Period | 0 | 117 |
| Total, all-cause mortality | (Arm 2): Pegfilgrastim and TC: Follow-up Period | 0 | 118 |
| Total, other adverse events | (Arm 1): SPI-2012 and TC | 115 | 117 |
| Total, other adverse events | (Arm 2): Pegfilgrastim and TC | 116 | 118 |
| Total, other adverse events | (Arm 1): SPI-2012 and TC: Follow-up Period | 33 | 117 |
| Total, other adverse events | (Arm 2): Pegfilgrastim and TC: Follow-up Period | 48 | 118 |
| Total, serious adverse events | (Arm 1): SPI-2012 and TC | 12 | 117 |
| Total, serious adverse events | (Arm 2): Pegfilgrastim and TC | 19 | 118 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| (Arm 1): SPI-2012 and TC vs (Arm 2): Pegfilgrastim and TC: Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Trial comparisons |
| (Arm 1): SPI-2012 and TC vs (Arm 2): Pegfilgrastim and TC: Number of Participants With Neutropenic Complications in Cycle 1 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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