Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab

Phase 2 Unknown 150 enrolled National Cancer Center, Korea Asan Medical Center · collab Chung-Ang University · collab Korea University Anam Hospital · collab Samsung Medical Center · collab Seoul National University Bundang Hospital · collab Seoul National University Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive metastatic breast cancer patients.

Timeline

Start: 2012-07
Primary completion: 2017-12
Completion: 2017-12

Outcome

Missed primary endpoint

paper There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). PMID 31690831 ↗

Publications

Sim SH, Park IH, Jung KH, Kim SB, Ahn JH, Lee KH, Im SA, Im YH, Park YH, Sohn J, Kim YJ, Lee S, Kim HJ, Chae YS, Park KH, Nam BH, Lee KS, Ro J. Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). Br J Cancer. 2019 Dec;121(12):985-990. doi: 10.1038/s41416-019-0618-z. Epub 2019 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	1000 mg	—
Subject	Vinorelbine	Small molecule	20 mg/m2	—
Subject	Vinorelbine	Small molecule	30 mg/m2	—