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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)