A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05509790
• Other study ID #: 18291
• Secondary ID: J2J-MC-JZLF
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 9, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: April 1, 2025
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• LY3484356
Administered orally.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Wannan Medical College Yijishan Hospital	Wuhu Shi	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)	ORR	Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Secondary	Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)	DCR	Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Secondary	Progression-Free Survival (PFS)	PFS	Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)