YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer

NCT07461454 | Recruiting Phase 3 DMC

• 1 other identifier: YL202-CN-302-01
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief 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 factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.

Conditions

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 18 months

Secondary Outcomes (6)

• Overall Survival (OS)

  up to 36 months

• Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1

  up to 18 months

• Objective Response Rate (ORR)

  up to 18 months

• Duration of Response (DoR)

  up to 18 months

• Disease Control Rate (DCR)

  up to 18 months

Study Arms (2)

YL202

EXPERIMENTAL

Drug: YL202

Treatment of Physician's Choice (TPC)

ACTIVE COMPARATOR

TPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan

Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Sacituzumab govitecan

Interventions

YL202 DRUG

IV infusion on day 1 of each 21 day cycle

YL202

Eribulin DRUG

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice (TPC)

Capecitabine DRUG

1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle

Treatment of Physician's Choice (TPC)

Gemcitabine DRUG

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice (TPC)

Vinorelbine DRUG

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice (TPC)

Sacituzumab govitecan DRUG

10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice (TPC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Medilink Study Team

CONTACT

+86 0512-62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-02

Locations

CN (1)