Breast NeoplasmsPhase 1NCT05509790
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
A Phase 1 study testing LY3484356 in people with Breast Neoplasms, run by Eli Lilly and Company at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- LY3484356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesChina
- Study dates
- 9 Oct 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
4 sites in 1 country.
China4 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330025
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201315
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, 241001
About this study
Official title: A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
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.
- Conditions
- Breast Neoplasms
- Being tested
- LY3484356
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3484356Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3484356 Dose Level 1 | Experimental | Administered orally. Receives: Drug: LY3484356 |
| LY3484356 Dose Level 2 | Experimental | Administered orally. Receives: Drug: LY3484356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Plasma Concentration of LY3484356
PK: Plasma Concentration of LY3484356
Measured: 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 (3)
2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
ORR
Measured: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
DCR
Measured: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Progression-Free Survival (PFS)
PFS
Measured: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start9 Oct 2022
- Primary completion18 Feb 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509790
- Sponsor's protocol ID
- 18291
- Other IDs
- J2J-MC-JZLF
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY3484356 in Chinese Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05509790
- Acronym / sponsor ID
- 18291
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3484356 Dose Level 1 | Experimental | Drug: LY3484356Administered orally. |
| LY3484356 Dose Level 2 | Experimental | Drug: LY3484356Administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Have a serious concomitant systemic disorder
- Have visceral crisis
- Have a serious cardiac condition
- Have an acute leukemia or other relevant cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3484356Administered orally. | Drug | LY3484356 Dose Level 1, LY3484356 Dose Level 2 |
Primary outcome
Pharmacokinetics (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)
PK: Plasma Concentration of LY3484356
3 secondary outcomes
2. Percentage of Participants Who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Disease Control Rate (DCR): Percentage of Participants With a BOR of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Progression-Free Survival (PFS)
Time frame: Randomization to Disease Progression or Death from Any Cause (Estimated up to 28 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3484356 in people with Breast Neoplasms, run by Eli Lilly and Company at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.