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A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05509790
Collaborator
(none)
24
Enrollment
3
Locations
2
Arms
19.9
Anticipated Duration (Months)
8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Mar 29, 2023
Anticipated Study Completion Date :
Mar 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3484356 Dose Level 1

Administered orally.

Drug: LY3484356
Administered orally.
Experimental: LY3484356 Dose Level 2

Administered orally.

Drug: LY3484356
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (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)]

    PK: Plasma Concentration of LY3484356

Secondary Outcome Measures

  1. 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)]

    ORR

  2. 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)]

    DCR

  3. Progression-Free Survival (PFS) [Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)]

    PFS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wannan Medical College Yijishan Hospital Wuhu Shi Anhui China 241001
2 Hunan Cancer Hospital Changsha Hunan China 410013
3 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05509790
Other Study ID Numbers:
  • 18291
  • J2J-MC-JZLF
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 22, 2022