Back to results

A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

Primary Purpose

Breast Neoplasms

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

LY3484356

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Third Hospital of NanchangRecruiting
Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LY3484356 Dose Level 1

LY3484356 Dose Level 2

Arm Description

Administered orally.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Plasma Concentration of LY3484356

PK: Plasma Concentration of LY3484356

Secondary Outcome Measures

2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

ORR

Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

DCR

Progression-Free Survival (PFS)

PFS

Full Information

NCT ID

NCT05509790

First Posted

August 19, 2022

Last Updated

October 17, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05509790

Brief Title

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

2. Study Status

Record Verification Date

October 1, 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 9, 2022 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY3484356 Dose Level 1

Arm Type

Experimental

Arm Description

Administered orally.

Arm Title

LY3484356 Dose Level 2

Arm Type

Experimental

Arm Description

Administered orally.

Intervention Type

Drug

Intervention Name(s)

LY3484356

Intervention Description

Administered orally.

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK): Plasma Concentration of LY3484356

Description

PK: Plasma Concentration of LY3484356

Time Frame

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 Outcome Measure Information:

Title

2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

Description

ORR

Time Frame

Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

Title

Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Description

DCR

Time Frame

Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

Title

Progression-Free Survival (PFS)

Description

PFS

Time Frame

Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

There may be multiple sites in this clinical trial. ( 1-877-CTLILLY (1-877-285-4559) or

Phone

1-317-615-4559

ClinicalTrials.gov@lilly.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

The Third Hospital of Nanchang

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenyan Chen

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Zhang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer

We'll reach out to this number within 24 hrs