CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
lapatinib ditosylate +5 moredrug
Likely dose
Not stated in 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/NCT01688609
NCT01688609Phase 2Completed

Phase II Study of Lapatinib and Trastuzumab Followed by Concurrent Lapatinib, Trastuzumab, and Paclitaxel Followed by Surgery for Primary HER2-positive (HER2+) Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Sep 20, 2012·Updated Sep 11, 2017

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate, paclitaxel, and 4 other interventions for HER2-positive Breast Cancer and 2 related conditions. Completed, enrolled 18 participants across 3 sites in 2 countries.

Detailed Summary

This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab, paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2013
Study CompletionAug 15, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.8 years ago

Interventions

lapatinib ditosylatedrug

Given PO

paclitaxeldrug

Given IV

trastuzumabbiological

Given IV

therapeutic conventional surgeryprocedure

Undergo lumpectomy or mastectomy

pharmacological studyother

Correlative studies

laboratory biomarker analysisother

Correlative studies