A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer (NCT05509790) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
China17 participantsStarted 2022-10-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Native Chinese participants must be of an acceptable age to provide informed consent
* Have locally advanced (not amenable to curative treatment by surgery) or metastatic disease and be an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit
* Have a diagnosis of ER+, HER2- breast cancer
* Female participants have postmenopausal status due either surgical/natural menopause or ovarian suppression
* If postmenopausal status is due to ovarian suppression, participants must have a negative serum pregnancy test and agree to use highly effective, medically approved precautions to prevent pregnancy
* Have a performance status less than or equal to (≤)1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Must be able to swallow capsules/tablets
Exclusion Criteria:
* Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis
* Have a serious concomitant systemic disorder
* Human immunodeficiency virus (HIV) positive patients are excluded unless they are well controlled on highly active antiretroviral therapy with no evidence of autoimmune deficiency syndrome-defining opportunistic infections within the last 2 years, and cluster of differentiation 4 (CD4) count greater than (\>)350 cells/microliter (μL)
* Active hepatitis B or C virus infection
* Severe renal impairment, interstitial l…
What they're measuring
1
Pharmacokinetics (PK): Plasma Concentration of LY3484356
Timeframe: 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)