A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: LY3484356

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509790

18291

J2J-MC-JZLF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

LY3484356 Dose Level 1

Experimental group

Description:

Administered orally.

Treatment:

Drug: LY3484356

LY3484356 Dose Level 2

Experimental group

Description:

Administered orally.

Treatment:

Drug: LY3484356