CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Lapatinib +2 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/NCT00548184
NCT00548184Phase 2Completed

A Phase II Trial of Lapatinib and Trastuzumab With or Without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients

Baylor Breast Care Center·interventional·Posted Oct 23, 2007·Updated Nov 7, 2019

In Brief

A Phase 2 clinical trial evaluating Lapatinib, Trastuzumab, and 1 other intervention for Breast Cancer. Completed, enrolled 65 participants across 6 sites.

Detailed Summary

We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors. The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2007
Enrollment StartMay 1, 2008
Primary CompletionJan 1, 2011
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.7 years ago

Interventions

Lapatinibdrug

Monoclonal Antibody

Trastuzumabdrug

Monoclonal Antibody

Endocrinedrug

Hormonal Therapy