ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED OPEN-LABEL ACTIVE-CONTROLLED MULTICENTER TRIAL (EMERALD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Other Inclusion Criteria:

1) Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease n amenable or metastatic disease, meaning not amenable to curative therapy. 2)Subjects must be appropriate candidates for endocrine treatment with one medication ( monotherapy ) 3) Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease 4) Subjects must have ER+/HER2-tumor status 5) Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria. 6) Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).

1) Prior treatment with elacestrant, investigational SERD or investigational ER antagonist. 2) Prior anticancer or investigational drug treatment within the following windows: a.Fulvestrant treatment < 28 days before first dose of study drug b.Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects) c.Chemotherapy < 21 days before first dose of study drug d.Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor