NCT02643420

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

RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy. Each cycle was 21 days. Four cycles were evaluated in 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).

Conditions

• Neutropenia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	SPI-2012	Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
DRUG	Pegfilgrastim	Single-dose subcutaneous injection administered on Day 2 of each cycle
DRUG	Docetaxel	Standard therapy
DRUG	Cyclophosphamide	Standard therapy

Timeline

• Start date: 2016-01-19
• Primary completion: 2018-01-24
• Completion: 2018-10-31
• First posted: 2015-12-31
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

81 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study