Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL202 | Experimental |
| |
| Treatment of Physician's Choice (TPC) | Active Comparator | TPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL202 | Drug | IV infusion on day 1 of each 21 day cycle |
| |
| Eribulin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from randomization until the date of death due to any cause. | up to 36 months |
| Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medilink Study Team | Contact | +86 0512-62858368 | clinicaltrials@medilinkthera.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C490954 | eribulin |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| C000608132 | sacituzumab govitecan |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
PFS is defined as time from randomization until disease progression or death due to any cause.
| 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. | 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. | 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. | up to 18 months |
| Adverse Events (AEs) | Incidence and severity of AEs and clinically significant abnormal laboratory findings. | up to 36 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |