A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Summary

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

Timeline

Start

2012-11-27

Primary completion

2020-07-31

Completion

2020-07-31

Publications

• Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.
• Engebraaten O, Yau C, Berg K, Borgen E, Garred O, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z.
• Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.

Drugs

Indications