drugset / Trial / NCT01013740
Lapatinib in Combination With Vinorelbine
RandomizedCrossoverOpen-labelTreatment
Summary
This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.
Timeline
- Start
- 2009-11-25
- Primary completion
- 2012-08-21
- Completion
- 2016-03-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Lapatinib Plus Capecitabine vs Lapatinib Plus Vinorelbine; Hazard Ratio (HR) 0.84 (95% CI 0.53 to 1.35) NCT01013740 ↗
paper Results showed that the median PFS (primary endpoint) and OS (secondary endpoint) post-randomisation were comparable between treatment arms, with no new safety signals detected. PMID 26384789 ↗
Publications
- Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- Janni W, Sarosiek T, Karaszewska B, Pikiel J, Staroslawska E, Potemski P, Salat C, Brain E, Caglevic C, Briggs K, Mahood K, DeSilvio M, Marini L, Papadimitriou C. Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer. Breast. 2015 Dec;24(6):769-73. doi: 10.1016/j.breast.2015.08.005. Epub 2015 Sep 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Subject | Lapatinib | Small molecule | 1250 mg | Oral |
| Subject | Vinorelbine | Small molecule | 20 mg/m2 | Intravenous |