Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

NCT03501979 ↗

Phase 2 Terminated 17 enrolled University of Alabama at Birmingham Georgetown University · collab Indiana University · collab Johns Hopkins University · collab Seagen Inc. · collab Translational Breast Cancer Research Consortium · collab University of California, San Francisco · collab University of Chicago · collab University of Michigan · collab University of Texas · collab University of Washington · collab

NaSingle-groupOpen-labelTreatment

Summary

A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.

Timeline

Start: 2019-02-20
Primary completion: 2021-06-22
Completion: 2021-06-22

Publications

Murthy RK, O'Brien BJ, Berry DA, Singareeka-Raghavendra A, Monroe MG, Johnson J, White J, Schwartz-Gomez J, Topletz-Erickson A, Lobbous M, Riley K, Melisko M, Morikawa A, Ferguson SD, de Groot JF, Krop IE, Valero V, Rimawi MF, Wolff AC, Tripathy D, Lin NU, Stringer-Reasor EM. Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in women with HER2+ breast cancer: TBCRC049 phase 2 study results. Nat Cancer. 2026 Mar;7(3):424-434. doi: 10.1038/s43018-026-01120-7. Epub 2026 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Tucatinib	Small molecule	300 mg	Oral

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Summary

Timeline

Publications

Drugs

Indications