NCT05509790Active, not recruitingPhase 1
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 · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 19 Aug 2022
- Start date
- 9 Oct 2022
- Primary completion date
- 18 Feb 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05509790
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 9 Oct 2022 to the primary completion date, 18 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a serious cardiac condition
- Have an acute leukemia or other relevant cancers
- Known allergic reaction against any of the components of the study drug
Lab values
- 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
Other
- Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Have visceral crisis
- Females who are pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Third Hospital of Nanchang Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wannan Medical College Yijishan Hospital Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.