YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- YL202
- Eribulin
- Capecitabine
- Gemcitabine
- Vinorelbine
- Sacituzumab govitecan
Treatment groups
376 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov