Clinical trial NCT05509790: A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
Official title: A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Breast Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pharmacokinetics (PK): Plasma Concentration of LY3484356
timeFrame: 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:
measure: 2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
timeFrame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
measure: Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
timeFrame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Other outcomes:
Locations:
city: Wuhu Shi
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: