Locally Advanced or Metastatic Breast CancerPhase 3NCT07461454
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
A Phase 3 study testing YL202, Eribulin and Capecitabine in people with Locally Advanced or Metastatic Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- YL202, Eribulin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 30 Jun 2028
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
- Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy.
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.
- Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.
- Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
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- Have Adequate organ and bone marrow function within 7 days prior to the first dose.
- 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.
- Have a expected survival ≥ 3 months.
- Have ability and willingness to comply with protocol-specified visits and procedures.
Who cannot join
- Have prior treatment with an agent targeting HER3.
- Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
- Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
- 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.
- Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
- Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
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- Have clinically significant concomitant pulmonary diseases.
- Have uncontrolled pleural effusion, abdominal effusion.
- Have serious infection within 4 weeks prior to the first dose.
- Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
study coordinator
About this study
Official title: A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.
- Being tested
- YL202, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL202Drug
IV infusion on day 1 of each 21 day cycle
EribulinDrug
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
CapecitabineDrug
1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
GemcitabineDrug
1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
VinorelbineDrug
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
Sacituzumab govitecanDrug
10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| YL202 | Experimental | Not described Receives: Drug: YL202 |
| Treatment of Physician's Choice (TPC) | Active comparator | TPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan Receives: Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
PFS is defined as time from randomization until disease progression or death due to any cause.
Measured: up to 18 months
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Measured: up to 36 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
PFS is defined as time from randomization until disease progression or death due to any cause.
Measured: up to 18 months
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who have a CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.
Measured: up to 18 months
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented confirmed response until disease progression, as determined by BICR/Investigator assessment or death due to any cause.
Measured: up to 18 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have a CR, PR or SD, per RECIST 1.1, as determined by BICR/Investigator assessment, per RECIST 1.1.
Measured: up to 18 months
Adverse Events (AEs)
Incidence and severity of AEs and clinically significant abnormal laboratory findings.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start17 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461454
- Sponsor's protocol ID
- YL202-CN-302-01
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
- ClinicalTrials.gov ID
- NCT07461454
- Acronym / sponsor ID
- YL202-CN-302-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YL202 | Experimental | Drug: YL202 |
| Treatment of Physician's Choice (TPC) | Active comparator | Drug: Eribulin, Drug: Capecitabine, Drug: Gemcitabine, Drug: Vinorelbine, Drug: Sacituzumab govitecanTPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
- Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy.
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.
- Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.
- Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.
Key exclusion criteria (10 listed)
- Have prior treatment with an agent targeting HER3.
- Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
- Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
- 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.
- Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
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 |
|---|---|---|
| YL202IV infusion on day 1 of each 21 day cycle | Drug | YL202 |
| Eribulin1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice (TPC) |
| Capecitabine1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle | Drug | Treatment of Physician's Choice (TPC) |
| Gemcitabine1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice (TPC) |
| Vinorelbine25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice (TPC) |
| Sacituzumab govitecan10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice (TPC) |
Primary outcome
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: up to 18 months
PFS is defined as time from randomization until disease progression or death due to any cause.
6 secondary outcomes
Overall Survival (OS)
Time frame: up to 36 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
Time frame: up to 18 months
Objective Response Rate (ORR)
Time frame: up to 18 months
Duration of Response (DoR)
Time frame: up to 18 months
Disease Control Rate (DCR)
Time frame: up to 18 months
Adverse Events (AEs)
Time frame: up to 36 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 26 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YL202, Eribulin and Capecitabine in people with Locally Advanced or Metastatic Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Medilink Study Team (+86 0512-62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (time frame: up to 18 months). 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 26 May 2026.