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Active, not recruitingNCT05509790Updated Apr 13, 2026

A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

A Phase 1 interventional study of LY3484356 in Breast Neoplasms, sponsored by Eli Lilly and Company. Active, not recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 17 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    LY3484356 Dose Level 1

    Administered orally.

    Drug: LY3484356

  • Experimental
    LY3484356 Dose Level 2

    Administered orally.

    Drug: LY3484356

Interventions

  • DrugLY3484356

    Administered orally.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Plasma Concentration of LY3484356

    PK: Plasma Concentration of LY3484356

    Time frame: 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)

Secondary outcomes

  1. 2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

    ORR

    Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

  2. Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

    DCR

    Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

  3. Progression-Free Survival (PFS)

    PFS

    Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

07

Study locations

4 sites
  • Wannan Medical College Yijishan Hospital
    Wuhu, Anhui 241001, China
  • Hunan Cancer Hospital
    Changsha, Hunan 410013, China
  • The Third Hospital of Nanchang
    Nanchang, Jiangxi 330025, China
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 201315, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05509790
Responsible party
Sponsor
First posted
Aug 22, 2022
Start date
Oct 9, 2022
Primary completion
Feb 18, 2024
Completion
Dec 2026 (estimated)
Last update
Apr 13, 2026

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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