Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

Summary

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

Timeline

Start

2016-02-16

Primary completion

2026-09-04

Completion

2026-09-04

Outcome

Met primary endpoint

paper The partial response rate was 44% (95% CI, 22% to 69%), meeting the primary end point. PMID 29989854 ↗

Publications

• Mondaca S, Razavi P, Xu C, Offin M, Myers M, Scaltriti M, Hechtman JF, Bradley M, O'Reilly EM, Berger MF, Solit DB, Li BT, Abou-Alfa GK. Genomic Characterization of ERBB2-Driven Biliary Cancer and a Case of Response to Ado-Trastuzumab Emtansine. JCO Precis Oncol. 2019 Oct 17;3:PO.19.00223. doi: 10.1200/PO.19.00223. eCollection 2019.
• Li BT, Shen R, Buonocore D, Olah ZT, Ni A, Ginsberg MS, Ulaner GA, Offin M, Feldman D, Hembrough T, Cecchi F, Schwartz S, Pavlakis N, Clarke S, Won HH, Brzostowski EB, Riely GJ, Solit DB, Hyman DM, Drilon A, Rudin CM, Berger MF, Baselga J, Scaltriti M, Arcila ME, Kris MG. Ado-Trastuzumab Emtansine for Patients With HER2-Mutant Lung Cancers: Results From a Phase II Basket Trial. J Clin Oncol. 2018 Aug 20;36(24):2532-2537. doi: 10.1200/JCO.2018.77.9777. Epub 2018 Jul 10.

Drugs

Indications