A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

Trial Title: A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

NCT ID: NCT05509790

Condition: Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: LY3484356
Description: Administered orally.
Arm group label: LY3484356 Dose Level 1
Arm group label: LY3484356 Dose Level 2

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Wannan Medical College Yijishan Hospital

Address:
City: Wuhu Shi
Zip: 241001
Country: China

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: The Third Hospital of Nanchang

Address:
City: Nanchang
Zip: 330025
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 201315
Country: China

Start date: October 9, 2022

Completion date: December 2025

Lead sponsor:
Agency: Eli Lilly and Company
Agency class: Industry

Source: Eli Lilly and Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05509790