CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Trastuzumab +3 moredrug
Likely dose
Trastuzumab 4mg/kgfrom 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/NCT00524303
NCT00524303Phase 2Completed
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Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer

GlaxoSmithKline·interventional·Posted Sep 3, 2007·Updated Nov 11, 2016

In Brief

A Phase 2 clinical trial evaluating Trastuzumab, Paclitaxel, and 2 other interventions for Neoplasms, Breast. Completed, enrolled 100 participants across 23 sites.

Detailed Summary

This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 3, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2010
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.8 years ago

Interventions

Trastuzumabdrug

4mg/kg IV loading dose followed by 2mg/kg IV weekly

Paclitaxeldrug

80mg/m2 IV weekly for 4 (21 day) cycles

FEC75drug

5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles

Lapatinibdrug

1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3