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

NCT02953340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2022-03-02

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-06-08
Completion
2019-05-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hungary
  • India
  • Poland
  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953340 on ClinicalTrials.gov