Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Summary

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

Timeline

Start

2021-01-11

Primary completion

2023-11-01

Completion

2026-04-30

Publications

• Okines AFC, Curigliano G, Mizuno N, Oh DY, Rorive A, Soliman H, Takahashi S, Bekaii-Saab T, Burkard ME, Chung KY, Debruyne PR, Fox JR, Gambardella V, Gil-Martin M, Hamilton EP, Monk BJ, Nakamura Y, Nguyen D, O'Malley DM, Olawaiye AB, Pothuri B, Reck M, Sudo K, Sunakawa Y, Van Marcke C, Yu EY, Ramos J, Tan S, Bieda M, Stinchcombe TE, Pohlmann PR. Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial. Nat Med. 2025 Mar;31(3):909-916. doi: 10.1038/s41591-024-03462-0. Epub 2025 Jan 17.
• Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. J Clin Oncol. 2023 Dec 20;41(36):5569-5578. doi: 10.1200/JCO.23.00606. Epub 2023 Sep 26.

Drugs

Indications