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NCT00194753 · ClinicalTrials.gov registry record · Phase 2

Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12

A Phase 2 study, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00194753: Completed Phase 2 study, sponsored by University of Washington.

NCT00194753 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00194753, a Phase 2 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG G-CSF
  • DRUG Paclitaxel

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2001-12
Est. Completion 2011-03
Phase Phase 2
University of Washington

1,048 total trials

What the finished NCT00194753 record still lists

NCT00194753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT00194753 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00194753 about?

NCT00194753 is a clinical study titled "Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12". The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dos...

What is the current status of trial NCT00194753?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2001-12. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00194753?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), G-CSF (DRUG), Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT00194753?

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 NCT00194753's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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 NCT00194753, the US trial registry maintained by the National Library of Medicine. NCT00194753 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.