Results From the EPO-ANE-3010 Study Consistent With US Black Box Labeling

Summary

The phase 3, randomized, noninferiority EPO-ANE-3010 study was conducted, at the request of the United States Food and Drug Administration, in 2098 patients with metastatic breast cancer, to address safety concerns regarding erythropoiesis-stimulating agents. Compared with standard supportive care, epoetin alfa treatment did not meet the protocol-defined noninferiority criteria.

  • safety
  • progression-free survival
  • erythropoiesis-stimulating agents
  • epoetin alfa
  • metastatic breast cancer
  • A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
  • EPO-ANE-3010
  • NCT00338286
View Full Text
Back to top

Tools

View Full Page PDF
Citation Tools
Email
Results From the EPO-ANE-3010 Study Consistent With US Black Box Labeling
Permalink: Copy
Linkedin Share Button del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo StumbleUpon logo

Table of contents

Cited By...

  • No citing articles found.

Keywords

safety
progression-free survival
erythropoiesis-stimulating agents
epoetin alfa
metastatic breast cancer
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
EPO-ANE-3010
NCT00338286