EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Inclusion Criteria:
Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
Must be deemed appropriate for treatment with endocrine therapy
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion Criteria:
Sacramento, California 95817, United States
Louisville, Kentucky 40202, United States
CABA, Buenos Aires F.D. 1125, Argentina
Capital, Córdoba Province X5008HHW, Argentina
São Paulo, 01317-001, Brazil
Luoyang, Henan 471003, China
Mönchengladbach, North Rhine-Westphalia 41061, Germany
Otashi, Gunma 373-8550, Japan
Tomitake, Nagano 381-8551, Japan
Shinagawa, Tokyo 142-8555, Japan
Cheonan-si, Chungcheongnam-do [Chungnam] 31151, South Korea
Namdong-gu, Incheon-gwangyeoksi [Incheon] 21565, South Korea
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea
Stanbul, Istanbul 34214, Turkey (Türkiye)
Üsküdar / Stanbul, Istanbul, Turkey (Türkiye)
Ankara, 06200, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Kryvyi Rih, Dnipropetrovsk Oblast 50048, Ukraine
Odesa, Odesa Oblast 65025, Ukraine
Lutsk, Volyn Oblast 43018, Ukraine