West Cancer Center

BREAST: Early: Supportive Care: Growth Factor: Receiving TC chemo: "ADVANCE"

Randomized trial of SPI-2012 versus pegfilgrastim in the management of chemotherapy induced neutropenia in breast cancer patients receiving docetaxel and cyclophosphamide

Title

Spectrum SPI-GCF-301

Study Title

Randomized trial of SPI-2012 versus pegfilgrastim in the management of chemotherapy induced neutropenia in breast cancer patients receiving docetaxel and cyclophosphamide

Site Link

NCT02643420

Malignancy

x- Breast Cancer, Early Breast Cancer, IDC, ILC

Stage

Stage 2

Disease Setting

Adjuvant or neoadjuvant

Line Of Therapy

N/A

Investigational Agent

SPI-2012

Drug Class

Long-acting myeloid growth factor

Lee Schwartzberg, MD

Sponsor

Spectrum Pharmaceuticals, Inc

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

NCT02643420

Key Eligibility Criteria Details

New diagnosis of early-stage breast cancer (Stage I to Stage IIIA)
Candidate for/plan to receive adjuvant or neoadjuvant TC chemo (docetaxel/cyclophosphamide)
ECOG PS 0-2
No locally recurrent, metastatic, or contralateral breast CA
No other concurrent adjuvant therapy
No prior exposure to myeloid growth factors
No surgery or radiation within 30 days of enrollment
No active concurrent malignancy
Labs wnl as per protocol

Objective

Primary- Duration of severe neutropenia in C1: Secondary- Time to ANC recovery in C1, Depth of ANC nadir in C1, Incidence of FN in C1

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any

Dosing Frequency

Control Agents

Pegfilgrastim

Study Protocol

Randomized