New hope for advanced breast cancer: YL202 takes on standard treatments in major trial
NCT ID NCT07461454
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tests whether the experimental drug YL202 works better than standard treatments (like eribulin or capecitabine) for people with a common type of advanced breast cancer (HR+/HER2-) that has not responded to at least one chemotherapy. About 376 participants will be randomly assigned to receive YL202 or a doctor-chosen standard therapy. The main goal is to see how long the cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 376 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form. 2. Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy. 3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage. 4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1. 5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 7. Have Adequate organ and bone marrow function within 7 days prior to the first dose. 8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug. 9. Have a expected survival ≥ 3 months. 10. Have ability and willingness to comply with protocol-specified visits and procedures. Exclusion Criteria: 1. Have prior treatment with an agent targeting HER3. 2. Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor. 3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug. 4. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study. 5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression. 6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease. 7. Have clinically significant concomitant pulmonary diseases. 8. Have uncontrolled pleural effusion, abdominal effusion. 9. Have serious infection within 4 weeks prior to the first dose. 10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 201321, China
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Other studies related to the condition(s) this trial covers.
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- New drug YL202 targets Hard-to-Treat breast cancers