Journal article

Phase 1b clinical trial of ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer

Laura M Spring, Shealagh L Clark, Tianyu Li, Shom Goel, Nabihah Tayob, Elene Viscosi, Elizabeth Abraham, Dejan Juric, Steven J Isakoff, Erica Mayer, Beverly Moy, Jeffrey G Supko, Sara M Tolaney, Aditya Bardia



Patients with HER2+ metastatic breast cancer are often treated with a multitude of therapies in the metastatic setting, and additional strategies to prolong responses to anti-HER2 therapies are needed. Preclinical evidence suggests synergy between cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors and anti-HER2 therapies. We conducted a phase 1b study of ribociclib and ado-trastuzumab emtansine (T-DM1) in patients with advanced/metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane in any setting, with four or fewer prior lines of therapy in the metastatic setting. A standard 3 + 3 dose-escalation design was used to evaluate various doses of ribociclib in c..

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Awarded by National Cancer Institute

Awarded by National Health and Medical Research Council of Australia

Awarded by Susan G. Komen for the Cure

Funding Acknowledgements

This trial was an investigator-initiated study sponsored by Novartis. Dr. Spring is supported by National Cancer Institute grant K12CA087723, Terri Brodeur Breast Cancer Foundation grant, Breast Cancer Alliance grant, and a Massachusetts General Hospital ESCCO Breast Cancer Research Fund grant. Dr. Goel is supported by the National Health and Medical Research Council of Australia (Investigator Grant GNT1177357), Susan G. Komen for the Cure (CCR18547966), and the Royal Australasian College of Physicians (Research Establishment Fellowship).