New hope for advanced breast cancer: early trial of oral drug LY3484356 begins
NCT ID NCT05509790
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
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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 Hide 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
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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The Third Hospital of Nanchang
Nanchang, Jiangxi, 330025, China
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Wannan Medical College Yijishan Hospital
Wuhu, Anhui, 241001, China
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