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Recruiting NCT07461454

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

Phase III Interventional Locally Advanced or Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YL202, Eribulin, Capecitabine, Gemcitabine.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug YL202
    IV infusion on day 1 of each 21 day cycle
  • Drug Eribulin
    1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
  • Drug Capecitabine
    1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
  • Drug Gemcitabine
    1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
  • Drug Vinorelbine
    25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
  • Drug Sacituzumab govitecan
    10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle

Primary outcome measures

  • Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [Time frame: up to 18 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07461454 · YL202-CN-302-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗