CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,098 enrolled
Drug / intervention
epoetin alfa + packed RBC transfusion +1 moredrug
Likely dose
epoetin alfa + packed RBC transfusion 40,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00338286
NCT00338286Phase 3Completed
CompareCT.gov

A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Janssen Research & Development, LLC·interventional·Posted Jun 20, 2006·Updated Mar 19, 2018

In Brief

A Phase 3 clinical trial evaluating Standard supportive care (packed RBC transfusion) and epoetin alfa + packed RBC transfusion for Breast Cancer and Neoplasm Metastasis. Completed, enrolled 2,098 participants across 174 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Neoplasm Metastasis
CountriesArgentina, Brazil, Bulgaria, Chile, Colombia, Ecuador, Georgia, Hong Kong, India, Indonesia, Malaysia, Mexico, North Macedonia, Philippines, Poland, Romania, Russia, South Africa, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartMar 2, 2006
Primary CompletionJul 7, 2014
Study CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.0 years ago

Interventions

Standard supportive care (packed RBC transfusion)other

Per doctor prescription

epoetin alfa + packed RBC transfusiondrug

40,000 IU SC once a week.