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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT01423123

Public ClinicalTrials.gov record NCT01423123. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 10:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Dose-Escalation Study Evaluating the Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01423123
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
NSABP Foundation Inc
Network
Enrollment
21 participants

Conditions and interventions

Conditions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2011 (Type not available)
Primary completion
Aug 2012 (Actual)
Completion
Mar 2014 (Actual)
Last update posted
Jul 8, 2014

2011 – 2014

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Cancer Institute of New Jersey New Brunswick New Jersey 08901 —
NSABP Foundation, Inc. Pittsburgh Pennsylvania 15212 —
University of Pittsburgh Pittsburgh Pennsylvania 15232-1305 —
West Virginia University Hospitals Morgantown West Virginia 26506-9162 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01423123, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2014 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01423123 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →