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To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108, toripalimab and eribulin | Experimental |
| |
| LM-108, toripalimab and nab-paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 | Drug | LM-108, 10mg/kg, d1, q6w |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DoR | Duration of overall response | 6 weeks |
| DCR | Disease control rate | 6 weeks |
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Inclusion Criteria:
Age 18-75 years old (including boundary value), no gender limit;
ECOG score 0-1;
Expected survival ≥3 months;
Unresectable or metastatic or postoperative recurrent, histologically confirmed advanced triple-negative breast cancer. Triple-negative breast cancer is defined as: ER, PR and HER2 are negative. ER-negative and PR-negative are defined as tumors without positive staining, the proportion of cells in all tumor cells is <1%; HER2-negative is defined as: HER2 (0), HER2 (1+) or HER2 (2+) detected by immunohistochemistry but negative by fluorescence in situ hybridization (FISH); Cohort 2 requires histological confirmation of PD-L1 CPS ≥ 1;
Cohort 1 : at least one prior line at recurrence or metastasis setting with disease progression or intolerable toxicity. In this situation, patients are allowed to be enrolled: the time between the last intravenous dose of adjuvant chemotherapy and first recurrence or metastasis is ≤6 months. Cohort 2: no prior line at recurrence or metastasis setting is allowed, the time between the last intravenous dose of adjuvant chemotherapy and first recurrence or metastasis ≥12 months.;
Provide sufficient fresh tissue specimens for biomarker analysis before treatment;
According to RECISTv1.1 standard, there is at least 1 measurable lesion;
Appropriate bone marrow and organ function before first dose :
Be able to well communicate with the investigator and understand and comply with the requirements of this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biyun Wang | Contact | 18017312387 | pro_wangbiyun@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C490954 | eribulin |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Toripalimab | Drug | Toripalimab, 240 mg, d1, q3w |
|
| Eribulin | Drug | Eribulin 1.4 mg/m2, d1, 8 , q3w |
|
| Nab paclitaxel | Drug | Nab paclitaxel 125 mg/m2, d1, 8 , q3w |
|
| PFS | Progression-free survival | 6 weeks |
| OS | Overall survival | 6 weeks |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6 weeks |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |