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NCT Number: NCT05509790

A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wannan Medical College Yijishan Hospital, Wuhu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3484356

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (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)

    PK: Plasma Concentration of LY3484356

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)

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

    ORR

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

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

    DCR

  3. Progression-Free Survival (PFS)

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

    PFS

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 22, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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