Health TrialsbyHealthPanel

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

ConditionLocally Advanced or Metastatic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • YL202

    Drug

    IV infusion on day 1 of each 21 day cycle

  • Eribulin

    Drug

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

  • Capecitabine

    Drug

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

  • Gemcitabine

    Drug

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

  • Vinorelbine

    Drug

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

  • Sacituzumab govitecan

    Drug

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

Treatment groups

376 Participants
are divided into 2 treatment groups
Group A: YL202Experimental treatment 1 intervention
Group B: Treatment of Physician's Choice (TPC)Active comparator 5 interventions

Trial outcomes

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.

Time frame
up to 18 months

Secondary outcomes

1

Overall Survival (OS)

OS is defined as time from randomization until the date of death due to any cause.

Time frame
up to 36 months
2

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.

Time frame
up to 18 months
3

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.

Time frame
up to 18 months
4

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.

Time frame
up to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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