Trial · NCT02643420
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
NCT02643420, Phase 3, Completed, Spectrum Pharmaceuticals, Inc; results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE). Trials, record NCT02643420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02643420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
- NCT number
- NCT02643420
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 406 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Neutropenia, Breast Cancer
- Interventions
- SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
- First posted
- 2015-12-31
- Last updated
- 2022-03-02
- Results first posted
- 2022-03-02
Source ClinicalTrials.gov
Registered outcomes9
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 Days 4-15 in Cycle 1 (each cycle was 21 days) | DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1. |
| Secondary | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\^9/L. |
| Secondary | Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | 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 Days 4, 15 in Cycle 1 (each cycle was 21 days) | FN was defined as an oral temperature \> 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L. |
| Secondary | Duration of Severe Neutropenia in Cycle 2, 3 and 4 | Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days) | DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4. |
| Secondary | Number of Participants With Neutropenic Complications in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 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 was 21 days) | FN was defined as an oral temperature \> 38.3 degrees C (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L. |
| Secondary | Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 | Cycles 1 to 4 (each cycle was 21 days) | RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 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 for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events. |
Source ClinicalTrials.gov
Outcomes9
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 Days 4-15 in Cycle 1 (each cycle was 21 days) | The ITT population included all participants who were randomized. | days | MEAN |
| SECONDARY | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | The ITT population included all participants who were randomized. | days | MEAN |
| SECONDARY | Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | The ITT population included all participants who were randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | 10^9 ANC/L | MEAN |
| SECONDARY | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | The ITT population included all participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Severe Neutropenia in Cycle 2, 3 and 4 | Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days) | The ITT population included all participants who were randomized. | days | MEAN |
| SECONDARY | Number of Participants With Neutropenic Complications in Cycle 1 | Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days) | The ITT population included all participants who was 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 was 21 days) | The ITT population included all participants who were randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 | Cycles 1 to 4 (each cycle was 21 days) | Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population. | percentage of planned dose | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months) | Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population. Data was summarized and reported separately for Treatment Period and Follow-up Period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
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 | 0.20 | Standard Deviation 0.503 | days | |
| Duration of Severe Neutropenia (DSN) in Cycle 1 | Arm 2: Pegfilgrastim and TC | 0.35 | Standard Deviation 0.683 | days | |
| Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Arm 1: SPI-2012 and TC | 3.24 | Standard Deviation 3.565 | days | |
| Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 | Arm 2: Pegfilgrastim and TC | 3.49 | Standard Deviation 3.589 | days | |
| Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 | Arm 1: SPI-2012 and TC | 2.56 | Standard Deviation 3.086 | 10^9 ANC/L | |
| Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 | Arm 2: Pegfilgrastim and TC | 2.53 | Standard Deviation 3.317 | 10^9 ANC/L | |
| Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Arm 1: SPI-2012 and TC | 4 | Participants | ||
| Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Arm 2: Pegfilgrastim and TC | 2 | Participants | ||
| Duration of Severe Neutropenia in Cycle 2, 3 and 4 | Arm 1: SPI-2012 and TC | Cycle 2 | 0.13 | Standard Deviation 0.383 | days |
| Duration of Severe Neutropenia in Cycle 2, 3 and 4 | Arm 2: Pegfilgrastim and TC | Cycle 2 | 0.09 | Standard Deviation 0.374 | days |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
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 Docetaxel + Cyclophosphamide (TC) | 196 | |
| Overall Study | STARTED | Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | 210 | |
| Overall Study | Safety Population | Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | 197 | |
| Overall Study | Safety Population | Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | 208 | |
| Overall Study | COMPLETED | Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | 142 | |
| Overall Study | COMPLETED | Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | 145 | |
| Overall Study | NOT COMPLETED | Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | 54 | |
| Overall Study | NOT COMPLETED | Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | 65 |
Source ClinicalTrials.gov
Adverse events560
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 | Fatigue | General disorders | Arm 1: SPI-2012 and TC -Treatment Period | 120 | 197 | |
| other | Fatigue | General disorders | Arm 2: Pegfilgrastim and TC -Treatment Period | 124 | 208 | |
| other | Fatigue | General disorders | Arm 1: SPI-2012 and TC - Follow up Period | 14 | 197 | |
| other | Fatigue | General disorders | Arm 2: Pegfilgrastim and TC - Follow up Period | 8 | 208 | |
| other | Pyrexia | General disorders | Arm 1: SPI-2012 and TC -Treatment Period | 45 | 197 | |
| other | Pyrexia | General disorders | Arm 2: Pegfilgrastim and TC -Treatment Period | 45 | 208 | |
| other | Pyrexia | General disorders | Arm 1: SPI-2012 and TC - Follow up Period | 0 | 197 | |
| other | Pyrexia | General disorders | Arm 2: Pegfilgrastim and TC - Follow up Period | 1 | 208 | |
| other | Oedema peripheral | General disorders | Arm 1: SPI-2012 and TC -Treatment Period | 36 | 197 | |
| other | Oedema peripheral | General disorders | Arm 2: Pegfilgrastim and TC -Treatment Period | 28 | 208 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 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 -Treatment Period | 0 | 197 |
| Total, all-cause mortality | Arm 2: Pegfilgrastim and TC -Treatment Period | 1 | 208 |
| Total, all-cause mortality | Arm 1: SPI-2012 and TC - Follow up Period | 0 | 197 |
| Total, all-cause mortality | Arm 2: Pegfilgrastim and TC - Follow up Period | 1 | 208 |
| Total, other adverse events | Arm 1: SPI-2012 and TC -Treatment Period | 192 | 197 |
| Total, other adverse events | Arm 2: Pegfilgrastim and TC -Treatment Period | 203 | 208 |
| Total, other adverse events | Arm 1: SPI-2012 and TC - Follow up Period | 92 | 197 |
| Total, other adverse events | Arm 2: Pegfilgrastim and TC - Follow up Period | 82 | 208 |
| Total, serious adverse events | Arm 1: SPI-2012 and TC -Treatment Period | 36 | 197 |
| Total, serious adverse events | Arm 2: Pegfilgrastim and TC -Treatment Period | 29 | 208 |
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 Neutropenic Complications in Cycle 1 | Trial comparisons |
| Arm 1: SPI-2012 and TC vs Arm 2: Pegfilgrastim and TC: Number of Participants With Febrile Neutropenia (FN) 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02643420
GET https://conductscience.org/api/trials/v1/NCT02643420/results?page=2