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A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

NCT00338286 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2098

Last updated 2018-03-19

Study results available
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Summary

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

Conditions

Interventions

OTHER

Standard supportive care (packed RBC transfusion)

Per doctor prescription

DRUG

epoetin alfa + packed RBC transfusion

40,000 IU SC once a week.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-02
Primary Completion
2014-07-07
Completion
2017-01-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Ecuador
  • Georgia
  • Hong Kong
  • India
  • Indonesia
  • Malaysia
  • Mexico
  • North Macedonia
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT00338286 on ClinicalTrials.gov