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This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.
Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.
The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SG plus Toripalimab | Experimental | Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. |
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| Nab-Paclitaxel plus Toripalimab | Active Comparator | Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan (SG) | Drug | Sacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria. | From randomization until disease progression or death, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from randomization to death from any cause. The event will be recorded regardless of cause and assessed continuously until the end of study follow-up. | From randomization until death, assessed up to 48 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
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| Toripalimab | Drug | Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. |
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| Nab-paclitaxel | Drug | Nab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. |
|
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR), confirmed at least 4 weeks after the initial response, as assessed by investigators according to RECIST version 1.1 criteria. |
| From first dose to first confirmed response, assessed up to 36 months |
| Duration of Response (DOR) | Duration of Response (DOR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurs first, as assessed by investigators according to RECIST version 1.1 criteria. | From first response until progression or death, assessed up to 36 months |
| Time to Response (TTR) | Time to Response (TTR) is defined as the time from randomization to the first documentation of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST version 1.1 criteria. | From randomization to first response, assessed up to 36 months |
| Incidence of Adverse Events and Serious Adverse Events | Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed from the first dose through 30 days after the last dose, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. | From first dose until 30 days after last dose |
| 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 |
|---|---|
| C000608132 | sacituzumab govitecan |
| C000656314 | toripalimab |
| C520255 | 130-nm albumin-bound paclitaxel |
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