A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results.
E HamiltonM OliveiraN TurnerJ García-CorbachoC HernandoE M CiruelosP KabosM Ruiz-BorregoA ArmstrongM R PatelC VaklavasC TwelvesV BoniJ IncorvatiT BrierL GibbonsT KlinowskaJ P O LindemannC J MorrowA SykesR D BairdPublished in: Annals of oncology : official journal of the European Society for Medical Oncology (2024)
Camizestrant is a next-generation oral selective ER antagonist and degrader (SERD) and pure ER antagonist with a tolerable safety profile. The pharmacokinetics profile supports once-daily dosing, with evidence of pharmacodynamic and clinical efficacy in heavily pre-treated patients, regardless of ESR1m. This study established 75-, 150-, and 300-mg QD doses for phase II testing (SERENA-2, NCT04214288 and SERENA-3, NCT04588298).