CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 80 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01423123
NCT01423123Phase 1Completed
CompareCT.gov

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

NSABP Foundation Inc·interventional·Posted Aug 25, 2011·Updated Jul 8, 2014

In Brief

A Phase 1 clinical trial evaluating Paclitaxel, trastuzumab, and 1 other intervention for Breast Cancer. Completed, enrolled 21 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2011
Enrollment StartMay 1, 2011
Primary CompletionAug 1, 2012
Study CompletionMar 1, 2014
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

Paclitaxeldrug

80 mg/m2 IV on days 1, 8, and 15 every 28 days until disease progression.

trastuzumabbiological

4 mg/kg IV loading dose, then 2 mg/kg IV weekly until disease progression.

Neratinibdrug

Dose level 1: 120 mg/day orally; Dose level 2: 160 mg/day orally; Dose level 3: 240 mg/day orally; Dose level 4: 200 mg/day orally.