Randomized phase 2 trial of alisertib with or without fulvestrant for endocrine-resistant metastatic breast cancer
Dr. Tufia Haddad
Alisertib, a selective inhibitor of aurora A kinase, upregulates ERα and restores endocrine sensitivity in preclinical metastatic breast cancer (mBC) models. The multicenter phase 2 TBCRC041 randomized clinical trial evaluated alisertib with or without fulvestrant for endocrine-resistant, HER2-negative mBC in postmenopausal patients who had received prior CDK 4/6 inhibitors. Adding fulvestrant to alisertib did not improve ORR or PFS, but promising clinical activity was observed with alisertib monotherapy. The overall safety profile was tolerable (visual abstract).
