At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 57 enrolled

Drug / intervention

Lapatinib oral tablets +1 moredrug

Likely dose

Lapatinib oral tablets 410 mgfrom 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/NCT00356811

NCT00356811Phase 2Completed

Compare CT.gov

An Open-label, Single-arm, Multi-centre, Phase II Study of Oral Lapatinib in Combination With Paclitaxel as First-line Treatment for ErbB2-amplified Metastatic Breast Cancer Patients

GlaxoSmithKline·interventional·Posted Jul 26, 2006·Updated Jul 21, 2014

In Brief

A Phase 2 clinical trial evaluating Lapatinib oral tablets and Paclitaxel infusion for Neoplasms, Breast. Completed, enrolled 57 participants across 13 sites in 4 countries.

Detailed Summary

This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNeoplasms, Breast

CountriesLatvia, Poland, Romania, Russia

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2006

First PostedJul 2006

Primary CompletionMar 2008

Study CompletionDec 2013

TodayJul 2026

First PostedJul 26, 2006

Enrollment StartMay 1, 2006

Primary CompletionMar 1, 2008

Study CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 19.9 years ago

Interventions

Lapatinib oral tabletsdrug

Lapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.

Paclitaxel infusiondrug

Subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.