drugset / Trial / NCT00558103

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

NCT00558103 ↗

Phase 2 Completed 163 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Timeline

Start
2007-12
Primary completion
2011-05
Completion
2011-12

Outcome

Met primary endpoint

registry p <0.001; Percentage of participants 47 (90% CI 32.8 to 62.1) NCT00558103 ↗

registry p <0.001; Percentage of participants 58 (90% CI 43.3 to 71.5) NCT00558103 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule — Oral
Subject Pazopanib Small molecule — Oral

Indications