Protocol Title: Elacestrant in women and men with CDK4/6 inhibitor-naïve estrogen receptor positive, HER2 negative metastatic breast cancer: An open-label multicenter phase 2 study (ELCIN)

Sponsor: Stemline Therapeutics

Protocol Number: STML-ELA-0322 (ELCIN)

Key Criteria

§  Women or men > 18 y/o
§  Premenopausal/perimenopausal women and men must be concurrently treated with LHRH agonist at least four weeks before first dose and during study
§  Patient has documented histopathological or cytological confirmed ER+, HER2- breast cancer
·         ER+ if ≥10% of tumor cells demonstrate positive nuclear staining
§  Patient has received at least one (up to two) prior hormonal therapy in advanced/metastatic setting
§  There is at least one measurable lesion per RECIST v1.1 or mainly lytic bone lesion
Excluded if
§  Patient has received prior treatment with any of the following agents in the advanced/metastatic setting.
·         Chemotherapy
·         CDK4/6 inhibitors
·         Elacestrant
·         Other investigational selective estrogen receptor degraders (SERDs) or alike
·         Selective estrogen receptor modulators (SERMs)
·         Selective estrogen receptor covalent antagonists (SERCANs)
·         Complete estrogen receptor antagonists (CERANs)
·         Proteolysis-targeting chimeras (PROTACs),
§  Patient has active/newly diagnosed CNS metastases (including meningeal carcinomatosis)
§  Patient has visceral crisis that is at risk of life-threatening complications in the short term
§  Patient has concurrent malignancy or history of invasive malignancy within 3 years of enrollment
§  Patient is unable to take oral medication, experiences refractory or chronic nausea, has GI condition (including significant gastric or bowel resection), history of malabsorption syndrome, or any other gastrointestinal condition that may impact absorption

Talking Points

§  Study drug: Elacestrant acts as a selective estrogen receptor degrader
§  Route of administration: PO, tablets
§  Indication: patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapy and NO prior CDK4/CDK6 inhibitors in the metastatic setting
§  Study design: This study will assess the efficacy and safety of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who have not received prior CDK4/6 inhibitors in the metastatic setting
§  Treatment duration: treatment will continue until disease progression, death, development of unacceptable toxicity, withdrawal of consent, or other reasons. Average treatment duration is estimated to be 6 months
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