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The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 9MW2821 | Experimental | Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol |
|
| Active Comparator: Investigator's Choice of Chemotherapy | Active Comparator | Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821 | Drug | Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from the date of randomization until the date of death from any cause | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate per investigator | The percentage of subjects who experience a best response of either CR or PR. | Up to approximately 2 years |
| Duration of Response per investigator | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong Wu | Contact | 021-64175590 | wujiong1122@vip.sina.com | |
| Jian Zhang | Contact | 021-64175590 | syner2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| Chemotherapy | Drug | Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine. |
|
| Up to approximately 2 years |
| Time to response per investigator | Time from the date of randomization to the date of CR or PR. | Up to approximately 2 years |
| Disease Control Rate per investigator | The percentage of subjects who experience a best response of CR, PR or stable disease (SD). | Up to approximately 2 years |
| Progression Free Survival per investigator | Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause. | Up to approximately 2 years |
| Incidence of adverse events | Up to approximately 2 years |
| Incidence of Anti-Drug Antibody (ADA) | Up to approximately 2 years |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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