Phase 1  | Investigational Drug

EMBER-2; NCT04647487

Breast Cancer

Selective ER Degrader

A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Postmenopausal Women With Stage I-III, Estrogen-Receptor-Positive, HER2-Negative Breast Cancer*

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Key Inclusion Criteria
  • Invasive estrogen-receptor-positive (ER+), HER2-negative breast cancer
  • Willing and able to provide pre- and on-treatment tumor samples
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Able to swallow capsules
  • Postmenopausal women
Key Exclusion Criteria
  • Bilateral invasive or metastatic breast cancer
  • Plan to receive concurrent neoadjuvant therapy with any other nonprotocol anticancer therapy
  • Prior therapy (of any kind) for an invasive or noninvasive breast cancer
  • Prior radiotherapy to the ipsilateral chest wall for any malignancy
  • Prior antiestrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer
  • Prior hormone-replacement therapy within 4 weeks of the start of study treatment
  • Major surgery within 28 days prior to randomization to allow for postoperative healing of the surgical wound and site(s)
  • Certain infections such as hepatitis, tuberculosis, or HIV that are not well controlled
  • Another serious medical condition
This clinical trial is being conducted globally. 
LY3484356 is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.