Results
Headache, fatigue, toxicity, nausea and vomiting, mucocutaneous telangiectasia, gingival hemorrhage, headache, epistaxis
ADVERSE EVENTS, PROLIFERATION, GINGIVAL HEMORRHAGE, HAND SWELLING, EPISTAXIS, RESIDUAL DISEASE, LUMINAL B BREAST CANCER
Fifteen patients enrolled. The recommended phase 2 dose of everolimus in combination with letrozole and carotuximab was 10 mg PO daily. The most frequent adverse events were headache (67%), fatigue (47%), facial flushing and swelling (47%), gingival hemorrhage (40%), epistaxis (33%), nausea and vomiting (27%). Headache constituted a dose-limiting toxicity. At least two signs of mucocutaneous telangiectasia developed in 92% of patients. Carotuximab accumulated in the extravascular space and accelerated the biodistribution and clearance of everolimus. All patients had residual disease. Gene expression analyses were consistent with downregulation of genes involved in proliferation and DNA repair. Among 6 patients with luminal B breast cancer, 5 converted to luminal A after one cycle of therapy.