At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 406 enrolled
Drug / intervention
SPI-2012 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)
In Brief
A Phase 3 clinical trial evaluating SPI-2012, Pegfilgrastim, and 2 other interventions for Neutropenia and Breast Cancer. Completed, enrolled 406 participants across 81 sites in 3 countries.
Detailed Summary
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia, Breast Cancer
CountriesCanada, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionJan 2018
Study CompletionOct 2018
TodayJul 2026
First PostedDec 31, 2015
Enrollment StartJan 19, 2016
Primary CompletionJan 24, 2018
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.5 years ago
Interventions
SPI-2012drug
Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Pegfilgrastimdrug
Single-dose subcutaneous injection administered on Day 2 of each cycle
Docetaxeldrug
Standard therapy
Cyclophosphamidedrug
Standard therapy