USO 22101

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy 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 (J2J-MC-JZLH)

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER+, HER2 –  early stage, resected, invasive breast cancer without evidence of distant metastasis, must have undergone definitive loco-regional treatment, bilateral breast cancer diagnosed in both breasts simultaneously or within 6 months allowed if all tumors in both breasts are ER+, HER 2 -  and adequate surgery has been completed in both breasts, must have received at least 24 months but not more than 60 months of any adjuvant endocrine therapy, have an increased risk of disease recurrence based on clin-path features

-No: metastatic disease, inflammatory breast cancer at primary diagnosis, local or distant recurrence, different primary breast cancer, more than a 6 month consecutive gap in adjuvant endocrine therapy, completed or discontinued prior adjuvant endocrine therapy ˃ 6 months prior to screening, received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene, have serious pre-existing condition that in the opinion of the treating investigator would preclude participation in study, received a stem cell transplant, active bacterial or fungal infection or detectable viral infection

Available at:

• Chesapeake
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)
• Williamsburg