Protocol Title: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy (tamoxifen or aromatase inhibitor) in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (EMBER 4)

Sponsor: Eli Lilly and Company

Protocol Number: J2J-MC-JZLH

Key Criteria

§  ER+, HER2- , early stage, resected, invasive breast cancer without evidence of distant metastasis. If bilateral breast cancer, all lesions tested on both sides are ER+ and HER2-
§  Undergone definitive loco-regional therapy (surgery, with or without radiation, and/or systemic treatment)
§  Received at least 24 months (but no more than 60 months) of adjuvant endocrine therapy from time of adjuvant therapy initiation to signing consent. Neoadjuvant endocrine therapy DOES NOT count.
§  Men, premenopausal and perimenopausal women must receive GnRH agonist at least 28 days prior to study treatment
§  Patient has increased risk of disease recurrence
o   Excluded if
§  Metastatic disease or inflammatory breast cancer at primary diagnosis
§  Breast cancer recurrence
§  Different primary cancer
§  More than 6 month consecutive gap in therapy
§  Completed or discontinued estrogen therapy > 6 months before screening
§  Receiving exogenous reproductive hormone therapy (birth control, hormone replacement, megestrol acetate)
§  History of receiving estrogen therapy for breast cancer prevention
§  Serious cardiac condition
§  Received autologous or allogenic stem cell transplant

Talking Points

§  Investigation product drug class: Selective estrogen receptor degrader
§  Indication: patients with ER+, HER2- early breast cancer who are at an increased risk of recurrence based on clin-path features at diagnosis and have previously received 2 to 5 years of Adjuvant Endocrine Therapy
§  Treatment Duration: 5 years
§  Design: Patients will either receive Imlunestrant or one of the following endocrine therapies based on physician’s choice: Anastrozole, Letrozole, Tamoxifen, Exemestane
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