Breast Cancer Clinical Trial
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
Summary
The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
Eligibility Criteria
Inclusion Criteria:
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
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 α (PIK3Cα) 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 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 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
Exclusion Criteria:
Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
Participants must not have another serious medical condition
Participants must not have cancer of the central nervous system that is unstable
Participants must not be pregnant or breastfeeding
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There are 74 Locations for this study
Gilbert Arizona, 85234, United States More Info
Principal Investigator
Phoenix Arizona, 85054, United States More Info
Principal Investigator
Fayetteville Arkansas, 72703, United States More Info
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Beverly Hills California, 90211, United States More Info
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Los Angeles California, 90048, United States More Info
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Orange California, 92868, United States More Info
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San Francisco California, 94158, United States More Info
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Aurora Colorado, 80012, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Orlando Florida, 32827, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Chicago Illinois, 60611, United States More Info
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Indianapolis Indiana, 46250, United States More Info
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Baltimore Maryland, 21287, United States More Info
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Boston Massachusetts, 02114, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Minneapolis Minnesota, 55404, United States More Info
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Rochester Minnesota, 55905, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Commack New York, 11725, United States More Info
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New York New York, 10065, United States More Info
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New York New York, 10065, United States More Info
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Rochester New York, 14642, United States More Info
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Chapel Hill North Carolina, 27599, United States More Info
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Durham North Carolina, 27710, United States More Info
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Columbus Ohio, 43210, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Medford Oregon, 97504, United States More Info
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Pittsburgh Pennsylvania, 15213, United States More Info
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Providence Rhode Island, 02903, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Dallas Texas, 75246, United States More Info
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Dallas Texas, 75390, United States More Info
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Houston Texas, 77030, United States More Info
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San Antonio Texas, 78229, United States More Info
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San Antonio Texas, 78240, United States More Info
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The Woodlands Texas, 77380, United States More Info
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Tyler Texas, 75702, United States More Info
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Burlington Vermont, 05401, United States More Info
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Fairfax Virginia, 22031, United States More Info
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Roanoke Virginia, 24014, United States More Info
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Seattle Washington, 98109, United States More Info
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Darlinghurst New South Wales, 2010, Australia More Info
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Waratah New South Wales, 2298, Australia More Info
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Kurralta Park South Australia, 5037, Australia More Info
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Nedlands Western Australia, 6009, Australia More Info
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Nedlands Western Australia, 6009, Australia More Info
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Brussel - Capital , 1070, Belgium More Info
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Edegem , 2650, Belgium More Info
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Leuven , 3000, Belgium More Info
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Saint Herblain Cedex , 44805, France More Info
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Strasbourg , 67033, France More Info
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Chuo-ku Tokyo, 104-0, Japan More Info
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Seoul Korea, 03722, Korea, Republic of More Info
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Seoul Seoul, Korea, 03080, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
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Seoul , 06351, Korea, Republic of More Info
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Barcelona , 08035, Spain More Info
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Barcelona , 08036, Spain More Info
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Madrid , 28007, Spain More Info
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Madrid , 28034, Spain More Info
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Madrid , 28040, Spain More Info
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Madrid , 28041, Spain More Info
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Madrid , 28050, Spain More Info
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Madrid , 28050, Spain More Info
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Valencia , 46009, Spain More Info
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Valencia , 46010, Spain More Info
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Kaohsiung , 807, Taiwan More Info
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Taichung , 40447, Taiwan More Info
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Taipei , 10002, Taiwan More Info
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Taipei , 11217, Taiwan More Info
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