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NCT01328249 · ClinicalTrials.gov registry record · Phase 2

Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

A Phase 2 study, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
81
Enrollment target

NCT01328249: Completed Phase 2 study, sponsored by Eisai.

NCT01328249 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01328249, a Phase 2 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
81 participants
Enrollment target

Study Summary

The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.

Primary Outcome

The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collec

Interventions

  • DRUG eribulin mesylate

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2011-03-03
Est. Completion 2017-10-19
Phase Phase 2
Eisai

287 total trials

What the finished NCT01328249 record still lists

NCT01328249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).

The record links to 0 conditions, and to 1 intervention - of which eribulin mesylate is the first listed.

NCT01328249 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01328249 about?

NCT01328249 is a clinical study titled "Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer". The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.

What is the current status of trial NCT01328249?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2011-03-03. Estimated completion is 2017-10-19.

What interventions are being tested in trial NCT01328249?

The interventions under investigation include: eribulin mesylate (DRUG).

Who is sponsoring clinical trial NCT01328249?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01328249's enrollment target sits among peer trials

81 834th of 2000 higher than 1,159 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 NCT01328249, the US trial registry maintained by the National Library of Medicine. NCT01328249 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.