CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 237 enrolled
Drug / intervention
SPI-2012 +3 moredrug
Likely dose
Docetaxel 75mgfrom 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.

Search/NCT02953340
NCT02953340Phase 3Completed
CompareCT.gov

Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

Spectrum Pharmaceuticals, Inc·interventional·Posted Nov 2, 2016·Updated Mar 2, 2022

In Brief

A Phase 3 clinical trial evaluating SPI-2012, Pegfilgrastim, and 2 other interventions for Neutropenia and Breast Cancer. Completed, enrolled 237 participants across 74 sites in 6 countries.

Detailed Summary

The purpose of this study is to compare the efficacy 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia, Breast Cancer
CountriesCanada, Hungary, India, Poland, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2, 2016
Enrollment StartMay 10, 2017
Primary CompletionJun 8, 2018
Study CompletionMay 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.7 years ago

Interventions

SPI-2012drug

Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

Pegfilgrastimdrug

Subcutaneous injection administered on Day 2 of each cycle.

Docetaxeldrug

75mg/m\^2 IV infusion administered on Day 1 of each cycle

Cyclophosphamidedrug

600mg/m\^2 IV infusion administered on Day 1 of each cycle