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NCT00016406 · ClinicalTrials.gov registry record · Phase 3

S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer

A Phase 3 study, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 3
Development phase
399
Enrollment target

NCT00016406: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.

NCT00016406 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 399 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00016406, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 3
Development phase
399 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin, cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer.

Interventions

  • DRUG cyclophosphamide
  • DRUG doxorubicin
  • DRUG paclitaxel
  • BIOLOGICAL filgrastim
  • PROCEDURE surgery

Trial Details

FieldValue
Enrollment Target 399 participants
Start Date 2001-05
Est. Completion 2012-02
Phase Phase 3
SWOG Cancer Research Network

270 total trials

What the finished NCT00016406 record still lists

NCT00016406 is an interventional study that assigns participants to a tested intervention. The registered 399 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 (48% lower).

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00016406 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00016406 about?

NCT00016406 is a clinical study titled "S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer. PURPOSE: Randomized phase III trial to compare the eff...

What is the current status of trial NCT00016406?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2001-05. Estimated completion is 2012-02.

What interventions are being tested in trial NCT00016406?

The interventions under investigation include: cyclophosphamide (DRUG), doxorubicin (DRUG), paclitaxel (DRUG), filgrastim (BIOLOGICAL), surgery (PROCEDURE).

Who is sponsoring clinical trial NCT00016406?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00016406's enrollment target sits among peer trials

399 962nd of 2000 higher than 1,038 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 NCT00016406, the US trial registry maintained by the National Library of Medicine. NCT00016406 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.