A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

NCT05509790 | Active Not Recruiting Phase 1

• 2 other identifiers: 18291J2J-MC-JZLF
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Plasma Concentration of LY3484356

  PK: Plasma Concentration of LY3484356

  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 (3)

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

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

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

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

• Progression-Free Survival (PFS)

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

Study Arms (2)

LY3484356 Dose Level 1

EXPERIMENTAL

Administered orally.

Drug: LY3484356

LY3484356 Dose Level 2

EXPERIMENTAL

Administered orally.

Drug: LY3484356

Interventions

LY3484356 DRUG

Administered orally.

LY3484356 Dose Level 1; LY3484356 Dose Level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241001, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, 330025, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201315, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Imlunestrant

Condition Hierarchy (Ancestors)

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

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: October 9, 2022
• Primary Completion: February 18, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)