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NCT00591851 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT00591851: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00591851 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00591851, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study Summary

HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back. The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.

Primary Outcome

LVEF by Muga scan

Interventions

  • DRUG AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2004-12
Est. Completion 2008-06
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT00591851 record still lists

NCT00591851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) is the first listed.

NCT00591851 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00591851 about?

NCT00591851 is a clinical study titled "Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility". HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come...

What is the current status of trial NCT00591851?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2004-12. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00591851?

The interventions under investigation include: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) (DRUG).

Who is sponsoring clinical trial NCT00591851?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00591851's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 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 NCT00591851, the US trial registry maintained by the National Library of Medicine. NCT00591851 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.