CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 138 enrolled
Drug / intervention
Lapatinibdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed invasive breast cancer, stage IIIB/IIIC (with T4 lesion) or stage IV, incurable disease
  • ✓ECOG performance status 0 or 1
  • ✓Documented HER2 amplification by FISH
  • ✓Measurable disease by RECIST
Key exclusion· 5
  • ✕Prior chemotherapy, immunotherapy, biologic therapy, or anti-HER2 therapy (except adjuvant therapy if stopped ≥12 months before entry)
  • ✕Active brain metastases
  • ✕Bilateral breast cancer
  • ✕Bone metastases as the only disease site

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089999
NCT00089999Phase 2Completed
CompareCT.gov

A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients With Advanced or Metastatic Breast Cancer

GlaxoSmithKline·interventional·Posted Aug 23, 2004·Updated Feb 28, 2017

In Brief

A Phase 2 clinical trial evaluating Lapatinib for Neoplasms, Breast. Completed, enrolled 138 participants across 31 sites in 11 countries.

Detailed Summary

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesChile, Hong Kong, India, Malaysia, Mexico, Pakistan, Peru, Poland, Singapore, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 23, 2004
Enrollment StartJun 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.9 years ago

Interventions

Lapatinibdrug