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NCT00338286 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
2,098
Enrollment target

NCT00338286: Completed Phase 3 study, sponsored by Janssen Research & Development.

NCT00338286 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 2,098 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00338286, a Phase 3 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
2,098 participants
Enrollment target

Study 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.

Primary Outcome

Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last diseas

Interventions

  • OTHER Standard supportive care (packed RBC transfusion)
  • DRUG epoetin alfa + packed RBC transfusion

Trial Details

FieldValue
Enrollment Target 2,098 participants
Start Date 2006-03-02
Est. Completion 2017-01-31
Phase Phase 3
Janssen Research & Development

593 total trials

What the finished NCT00338286 record still lists

NCT00338286 is an interventional study that assigns participants to a tested intervention. Its 2,098 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher).

The record links to 0 conditions, and to 2 interventions - of which Standard supportive care (packed RBC transfusion) is the first listed.

NCT00338286 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00338286 about?

NCT00338286 is a clinical study titled "A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy". 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 guid...

What is the current status of trial NCT00338286?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,098 participants. The study started on 2006-03-02. Estimated completion is 2017-01-31.

What interventions are being tested in trial NCT00338286?

The interventions under investigation include: Standard supportive care (packed RBC transfusion) (OTHER), epoetin alfa + packed RBC transfusion (DRUG).

Who is sponsoring clinical trial NCT00338286?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00338286's enrollment target sits among peer trials

2,098 99th of 2000 higher than 1,902 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00338286, the US trial registry maintained by the National Library of Medicine. NCT00338286 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.