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NCT01106898 · ClinicalTrials.gov registry record · Phase 2

Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery

A Phase 2 study, sponsored by University of Nebraska.

Completed
Registry status
Phase 2
Development phase
112
Enrollment target

NCT01106898: Completed Phase 2 study, sponsored by University of Nebraska.

NCT01106898 is a Phase 2 study that has completed, run by University of Nebraska. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01106898, a Phase 2 study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
Phase 2
Development phase
112 participants
Enrollment target

Study Summary

This phase II trial studies the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating patients with stage I-II breast cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Primary Outcome

Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL trastuzumab

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2010-03-24
Est. Completion 2015-09-28
Phase Phase 2
University of Nebraska

407 total trials

What the finished NCT01106898 record still lists

NCT01106898 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).

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

NCT01106898 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01106898 about?

NCT01106898 is a clinical study titled "Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery". This phase II trial studies the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating patients with stage I-II breast cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different way...

What is the current status of trial NCT01106898?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2010-03-24. Estimated completion is 2015-09-28.

What interventions are being tested in trial NCT01106898?

The interventions under investigation include: laboratory biomarker analysis (OTHER), cyclophosphamide (DRUG), paclitaxel (DRUG), trastuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01106898?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01106898's enrollment target sits among peer trials

112 631st of 2000 higher than 1,369 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 NCT01106898, the US trial registry maintained by the National Library of Medicine. NCT01106898 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.