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NCT00081796 · ClinicalTrials.gov registry record · Phase 3

Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
438
Enrollment target

NCT00081796: Completed Phase 3 study, sponsored by Sanofi.

NCT00081796 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 438 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00081796, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
438 participants
Enrollment target

Study Summary

The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

Interventions

  • DRUG capecitabine
  • DRUG larotaxel (RPR109881, XRP9881)

Trial Details

FieldValue
Enrollment Target 438 participants
Start Date 2004-04
Est. Completion 2006-09
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00081796 record still lists

NCT00081796 is an interventional study that assigns participants to a tested intervention. The registered 438 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).

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

NCT00081796 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00081796 about?

NCT00081796 is a clinical study titled "Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer". The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

What is the current status of trial NCT00081796?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2004-04. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00081796?

The interventions under investigation include: capecitabine (DRUG), larotaxel (RPR109881, XRP9881) (DRUG).

Who is sponsoring clinical trial NCT00081796?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00081796's enrollment target sits among peer trials

438 874th of 2000 higher than 1,127 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 NCT00081796, the US trial registry maintained by the National Library of Medicine. NCT00081796 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.