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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLF | Other Identifier | Eli Lilly and Company |
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This is a study of LY3484356 in Chinese participants with advanced breast cancer. Participants must have breast cancer that is estrogen receptor positive (ER+), HER2 negative (HER2-). The purpose of this study is to measure how much LY3484356 gets into the bloodstream and how long it takes the body to remove it. The safety and effectiveness of LY3484356 will also be studied. Participation could last up to 28 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3484356 Dose Level 1 | Experimental | Administered orally. |
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| LY3484356 Dose Level 2 | Experimental | Administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3484356 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Plasma Concentration of LY3484356 | PK: Plasma Concentration of LY3484356 | Time Frame: Cycle 1, Day 1 through Day 3 and Day 17 through Day 18; Cycle 2 Day 1 (Cycle 1 = 30 days, Cycle 2 = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) | ORR | Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months) |
| Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
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Inclusion Criteria:
Exclusion Criteria:
Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis
Have a serious concomitant systemic disorder
Have visceral crisis
Have a serious cardiac condition
Have an acute leukemia or other relevant cancers
Females who are pregnant or lactating
Known allergic reaction against any of the components of the study drug
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wannan Medical College Yijishan Hospital | Wuhu | Anhui | 241001 | China | ||
| Hunan Cancer Hospital |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
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DCR |
| Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months) |
| Progression-Free Survival (PFS) | PFS | Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months) |
| Changsha |
| Hunan |
| 410013 |
| China |
| The Third Hospital of Nanchang | Nanchang | Jiangxi | 330025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 201315 | China |
| D017437 |
| Skin and Connective Tissue Diseases |