EMBER: A Study of LY3484356 in Patients with Breast or Other Non-Breast Cancers
- Conditions
- Malignancy
- Registration Number
- JPRN-jRCT2031200271
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 460
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.
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.
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
- Secondary Outcome Measures
Name Time Method