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NCT01423123 · ClinicalTrials.gov registry record · Phase 1

Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

A Phase 1 study, sponsored by NSABP Foundation.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT01423123 is a Phase 1 study that has completed, run by NSABP Foundation. The registered enrollment target is 21 participants.

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The verdict

NCT01423123, a Phase 1 study, has completed, sponsored by NSABP Foundation.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the safety and tolerability of the three-drug combination.

Interventions

  • DRUG Neratinib
  • DRUG Paclitaxel
  • BIOLOGICAL trastuzumab

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2011-05
Est. Completion 2014-03
Phase Phase 1

Sponsor

NSABP Foundation

44 total trials

What the Registry Record Tells You About NCT01423123

The ClinicalTrials.gov registry entry for NCT01423123 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Neratinib is the first listed.

NCT01423123 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01423123 about?

NCT01423123 is a clinical study titled "Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer". The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the safety and tolerability of th...

What is the current status of trial NCT01423123?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-05. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01423123?

The interventions under investigation include: Neratinib (DRUG), Paclitaxel (DRUG), trastuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01423123?

This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.