A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (EMBER)
The reason for this study is to see if the study drug LY3484356 alone or in combination with abemaciclib is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
Trial Summary
Key Requirements
Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.Participants Must:
Participants must have estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that may have spread to other part(s) of the body and has had up to 3 lines of standard therapy and progression while on endocrine-containing therapy for 24 months in the adjuvant setting or 6 months in advanced/metastatic setting OR have endometrioid endometrial cancer (EEC) having progressed on standard of care and must have had prior platinum-containing therapy
All study parts:
Participants must be willing to provide adequate archival tissue sample
Participants must be willing to use highly effective birth control
Participants must have adequate organ function
Participants must be able to swallow capsules
Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
Dose escalation:
Participants must have one of the following:
Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following:
Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor
Cohort E4: No prior everolimus. Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic (PIK3C) mutation as determined by local testing.
Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting.
Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.
Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease.
Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen.
Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy
Participants with ER+/HER2- breast cancer enrolled in this study must have either demonstrated prior sensitivity to endocrine therapy, to have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer
Participants Must Not:
Participants must not have another serious medical condition
Participants must not have cancer of the central nervous system that is not stable
Participants must not be pregnant or breastfeeding
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You will complete the questionnaire on another website.YesNo