Table 1.

VERITAC-2 key eligibility criteria.

Key inclusion criteria

Key exclusion criteria

– Women or men aged ≥18 years   ○ Women must be post-menopausal or if pre- or peri-menopausal,must agree to initiate or continue use of an LHRH agonist   ○ Men must agree to initiate or continue use of an LHRH agonist   ○ WOCBP and men must agree to use contraception – Confirmed ER+/HER2- locoregional recurrent or metastatic breast cancer – Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:   ○ 1 line of CDK4/6 inhibitor therapy in combination with ET (only 1 line of CDK4/6 inhibitor in any setting)   ○ ≤1 ET (in addition to CDK4/6 inhibitor with ET)   ○ Most recent ET given for ≥6 months prior to disease progressiona   ○ Radiological progression during or after the last line of therapy – ECOG performance status of 0 or 1 – Measurable disease evaluable per RECIST v1.1 or nonmeasurable bone-only disease

– Active brain metastases – Inflammatory breast cancer – Advanced, symptomatic visceral spread at risk of life-threatening complications in the short-term – Impaired cardiovascular function or clinically significant cardiovascular disease – Prior treatment with   ○ Vepdegestrant   ○ Fulvestrant   ○ Elacestrant   ○ mTOR, PI3K, or AKT pathway inhibitors   ○ PARP inhibitors   ○ Other investigational agents, including novel ET (SERDs, SERCAs, CERANs)   ○ Chemotherapy for advanced/metastatic disease

^aThe most recent ET may be the ET component of the CDK4/6 inhibitor line of therapy.

CERAN: Complete estrogen receptor antagonist; ECOG: Eastern Cooperative Oncology Group; ET: Endocrine therapy; RECIST: Response Evaluation Criteria in Solid Tumors; SERCA: Selective estrogen receptor covalent agonist; SERD: Selective estrogen receptor degrader; WOCBP: Women of childbearing potential.