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NCT00194727 · ClinicalTrials.gov registry record · Phase 2

Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer

A Phase 2 study, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00194727: Completed Phase 2 study, sponsored by University of Washington.

NCT00194727 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00194727, a Phase 2 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.

Interventions

  • DRUG Capecitabine
  • DRUG Vinorelbine

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2002-05
Est. Completion 2011-03
Phase Phase 2
University of Washington

1,048 total trials

What the finished NCT00194727 record still lists

NCT00194727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

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

NCT00194727 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00194727 about?

NCT00194727 is a clinical study titled "Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer". The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Sa...

What is the current status of trial NCT00194727?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2002-05. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00194727?

The interventions under investigation include: Capecitabine (DRUG), Vinorelbine (DRUG).

Who is sponsoring clinical trial NCT00194727?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00194727's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00194727, the US trial registry maintained by the National Library of Medicine. NCT00194727 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.