NCT02953340

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN). Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim). After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.

Conditions

• Neutropenia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	SPI-2012	Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
DRUG	Pegfilgrastim	Subcutaneous injection administered on Day 2 of each cycle.
DRUG	Docetaxel	75mg/m\^2 IV infusion administered on Day 1 of each cycle
DRUG	Cyclophosphamide	600mg/m\^2 IV infusion administered on Day 1 of each cycle

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-06-08
• Completion: 2019-05-06
• First posted: 2016-11-02
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

74 sites across 6 countries: United States, Canada, Hungary, India, Poland, South Korea

Regulatory

• FDA-regulated drug study