CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Paclitaxel +3 moredrug
Likely dose
Trastuzumab 6mg/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/NCT01827163
NCT01827163Phase 2Completed
CompareCT.gov

The Feasibility of Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 9, 2013·Updated Dec 18, 2019

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Trastuzumab, and 2 other interventions for HER2-Positive Early Stage Breast Cancer. Completed, enrolled 20 participants across 4 sites.

Detailed Summary

The purpose of this study is to study a new treatment for HER2-positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2-Positive Early Stage Breast Cancer
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.2 years ago

Interventions

Paclitaxeldrug

Trastuzumabdrug

The q 3 week trastuzumab may be started at the last dose of paclitaxel infusion or from 1-3 weeks after the last dose of paclitaxel. Trastuzumab may also be administered at a dose of 6mg/kg during the last dose of paclitaxel in the THL phase.

Lapatinibdrug

Pegfilgrastimdrug

Pegfilgrastim SQ is given on day # 2 of each paclitaxel cycle and may be dropped at the last paclitaxel infusion. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion.