A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)
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The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.
EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Actual Study Start Date :
April 21, 2021
Estimated Primary Completion Date :
October 17, 2022
Estimated Study Completion Date :
October 17, 2022
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Accepts Healthy Volunteers:
Have histologically confirmed invasive ER+, HER2- breast carcinoma
Be willing and able to provide pre- and on-treatment tumor samples
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
Have adequate organ function
Be able to swallow capsules
Be a postmenopausal woman
Have bilateral invasive breast cancer
Have metastatic breast cancer
Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy
Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer
Have had prior radiotherapy to the ipsilateral chest wall for any malignancy
Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer
Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment
Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s)
Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
Have another serious medical condition
Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years