This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days. Cohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Given orally
Given SC
Given orally
University of Alabama at Birmingham
Birmingham, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, United States
Change from Baseline in Antigen Kiel (Ki-67) Expression
Time frame: Baseline, Day 29
Rate of Symptomatic Ovarian Cysts
Time frame: Up to Day 180
Change from Baseline in Estrogen Receptor (ER) Expression
Time frame: Baseline, Day 29
Change from Baseline in Progesterone Receptor (PR) Expression
Time frame: Baseline, Day 29
Rate of Complex Ovarian Cysts
Time frame: Up to Day 180
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Banner MD Anderson Cancer Center at McKee Medical Center
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Altamonte Springs, Florida, United States
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Massachusetts General Hospital
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