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This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously treated with first-line or second-line systems. It is planned to enroll 78 subjects in this study. Subjects who meet the inclusion and exclusion criteria are divided into a random ratio of 1:1. The experimental group will receive QL1706 in combination with platinum chemotherapy selected by the investigator, and the control group will receive platinum chemotherapy selected by the investigator. A treatment cycle will be held every 3 weeks until disease progression or intolerable toxicity occurs. After subjects in the control group withdraw from the study, they are allowed to receive other treatments selected by the QL1706 co-investigators based on the subjects 'wishes. Efficacy assessments will be conducted every 6 weeks (42 days ±7 days) after treatment until disease progression, withdrawal of informed consent, death, or start of new antitumor therapy, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
| |
| Control Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | IV infusion, 5mg/kg, given every 3 weeks, every 3 weeks as a cycle; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-Free Survival (PFS) | The time interval between the start of study drug use and the patient's disease progression or death. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate(ORR) | Proportion of patients with complete response (CR) and partial response (PR) assessed according to RECIST 1.1 in solid tumors | assessed up to 36 months |
| disease control rate(DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MFei | Contact | +86 13710217780 | mafei2011@139.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 17 Panjiayuan Nan Li, Chaoyang District, Beijing | Beijing | Beijing Municipality | 100021 | China |
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| Cisplatin/ Carboplatin |
| Drug |
Cisplatin: 75mg/m2, intravenous infusion, Day 1 (or divided into 3 days), every 3 weeks as cycles; carboplatin: AUC5, intravenous infusion, Day 1, every 3 weeks as cycles; |
|
Proportion of patients with complete response, partial response, and stable response as assessed according to RECIST 1.1 in solid tumors.
| assessed up to 36 months |
| duration of response | Time from the start of complete response (CR) or partial response (PR) on the first tumor assessment to progression of disease (PD) or death from any cause on the first tumor assessment | assessed up to 36 months |
| overall survival(OS) | Time from start of study drug to death from any cause | assessed up to 36 months |
| adverse events | Incidence of adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), immune-related adverse events (irAEs) | assessed up to 36 months |
| 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 |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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