Clinical trial · Interventional
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3484356 | Drug | Imlunestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY3484356 Dose Level 1
- description
- Administered orally.
- interventionNames
- Drug: LY3484356
- type
- EXPERIMENTAL
- label
- LY3484356 Dose Level 2
- description
- Administered orally.
- interventionNames
- Drug: LY3484356
Primary outcomes (1)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea * 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
References
Publications (0)
Data not yet available