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NCT00006110 · ClinicalTrials.gov registry record · Phase 2

Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer

A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
82
Enrollment target

NCT00006110: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT00006110 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00006110, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
82 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.

Primary Outcome

Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL trastuzumab
  • PROCEDURE conventional surgery
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 1998-12
Est. Completion 2013-04
Phase Phase 2

What the finished NCT00006110 record still lists

NCT00006110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

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

NCT00006110 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00006110 about?

NCT00006110 is a clinical study titled "Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemothera...

What is the current status of trial NCT00006110?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 1998-12. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00006110?

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

Who is sponsoring clinical trial NCT00006110?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00006110's enrollment target sits among peer trials

82 830th of 2000 higher than 1,167 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 NCT00006110, the US trial registry maintained by the National Library of Medicine. NCT00006110 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.