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New hope for advanced breast cancer: early trial of oral drug LY3484356 begins

NCT ID NCT05509790

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an oral drug called LY3484356 in 17 Chinese patients with advanced ER+/HER2- breast cancer. The main goals are to see how the drug moves through the body and to check its safety. Researchers will also look for signs that the drug can shrink tumors or control the disease. Participation can last up to 28 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3484356 (an oral drug)
What this could lead to
If successful, this could lead to a new oral treatment option for Chinese patients with advanced ER+/HER2- breast cancer.
What could go wrong
This is a very early phase 1 study with only 17 participants, so results may not apply broadly. The drug may not prove effective or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201315, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330025, China

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001, China

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