Selective ER Degrader
Imlunestrant
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*
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Key Inclusion Criteria
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Diagnosis of estrogen-receptor-positive (ER+), HER2-negative (HER2-) early-stage, resected, invasive breast cancer without evidence of distant metastasis
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Participants must have received at least 24 months, but not more than 60 months, of any adjuvant endocrine therapy (ET) from time of adjuvant ET initiation
- Participants may have received neoadjuvant chemotherapy and/or targeted therapy with a cyclin-dependent kinase 4 and 6 (CDK4/6)- or polyadenosine diphosphate-ribose polymerase (PARP)- inhibitor
- Must have an increased risk of disease recurrence based on clinical-pathological risk features
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Key Exclusion Criteria
- Any evidence of metastatic disease (including contralateral axillary lymph node [ALN]) or inflammatory breast cancer at primary breast cancer diagnosis
- Greater than a 6-month consecutive gap in therapy during prior adjuvant ET
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening
- History of previous breast cancer are excluded, except for ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention
- Prior ET of any duration for breast cancer prevention (tamoxifen or aromatase inhibitors [AIs]) or raloxifene
- History of any other cancer
- Serious preexisting medical conditions