drugset / Trial / NCT00347919
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-08
- Completion
- 2015-03
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Cohort 1: Lapatinib 1500 mg vs Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg; p = 0.3724; NCT00347919 ↗
Publications
- Background Johnston SR, Gomez H, Stemmer SM, Richie M, Durante M, Pandite L, Goodman V, Slamon D. A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer. Breast Cancer Res Treat. 2013 Feb;137(3):755-66. doi: 10.1007/s10549-012-2399-4. Epub 2013 Jan 3.
- de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | 1000 mg | Oral |
| Subject | Lapatinib | Small molecule | 1500 mg | Oral |
| Subject | Pazopanib | Small molecule | 400 mg | Oral |
| Subject | Pazopanib | Small molecule | 800 mg | Oral |