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NCT00082095 · ClinicalTrials.gov registry record · Phase 3

To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Terminated
Registry status
Phase 3
Development phase
62
Enrollment target

NCT00082095: Clinical Trial Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT00082095 is a Phase 3 study that was terminated before completion, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00082095, a Phase 3 study, was terminated before completion, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

TERMINATED
Registry status
Phase 3
Development phase
62 participants
Enrollment target

Study Summary

The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

Primary Outcome

Time to disease progression is the duration in months from the date of randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study. Time to disease progression will be compared between patients treated with doxorubicin and capecitabine.

Interventions

  • DRUG Capecitabine
  • DRUG Pegylated liposomal doxorubicin

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2004-04
Est. Completion 2005-12
Phase Phase 3

Why NCT00082095 stopped before completion

NCT00082095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.

NCT00082095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00082095 about?

NCT00082095 is a clinical study titled "To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older". The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

What is the current status of trial NCT00082095?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2004-04. Estimated completion is 2005-12.

What interventions are being tested in trial NCT00082095?

The interventions under investigation include: Capecitabine (DRUG), Pegylated liposomal doxorubicin (DRUG).

Who is sponsoring clinical trial NCT00082095?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00082095's enrollment target sits among peer trials

62 1802nd of 2000 higher than 198 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 NCT00082095, the US trial registry maintained by the National Library of Medicine. NCT00082095 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.