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Triple-negative breast cancer (TNBC) lacks effective treatment options due to the absence of traditional therapeutic targets.This study is a multicentre, prospective trial. The primary objective of the trial was to evaluate the objective response rate to tslelizumab combined with eribulin in different subgroups(subgroup A: TMB High, B: PD-L1 positive,C, immunomodulatory (IM),D,NanoString superiority,E,other types)of relapse or metastasis TNBC after failure of second-line chemotherapy. Therefore, exploring new therapeutic options and identifying subgroups of patients who may benefit from special treatments has been a focal point of research. Doing so, we expect to guide new investigation efforts in this area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMB High group | Experimental |
| |
| PD-L1 positive group | Experimental |
| |
| Immunomodulatory (IM) group | Experimental |
| |
| NanoString superiority group | Experimental |
| |
| other types | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Eribulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from date of randomization to the date of death from any cause | Up to approximately 30 months |
| Progression-Free Survival (PFS) | PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. |
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Inclusion Criteria:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
Female patients aged 18-75 years (including cutoff value).
Eastern Cooperative Oncology Group Performance Status of 0-1.
Life expectancy ≥ 12 weeks.
Histopathologically confirmed recurrent (unresectable) or metastatic triple-negative breast cancer; ER and PR negative is defined as ER <1% positive, PR <1% positive. HER-2 negative is defined as HER-2 (-) or (1+) by immunohistochemistry, HER-2 (2+) must be tested by FISH with negative result, HER-2 (1+), FISH is optional and negative;
At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
Previously received more than 2 lines of systemic chemotherapy for metastatic breast cancer.(the adjuvant chemotherapy regimen administered after recurrence within 6 months was considered as the first-line chemotherapy regimen)
Adequate organ function, i.e. meeting the following criteria. Hb ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 109 /L; PLT ≥ 75 × 109 /L.
Liver function: total bilirubin TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN.
serum Cr ≤ 1.5×ULN. Left ventricular ejection fraction (LVEF) ≥ 50% QTcF(Fridericia correction) ≤ 470 ms
Subjects voluntarily joined the study, signed informed consent.
Exclusion Criteria:
All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, MD,PhD | Contact | +8664175590 | 85000 | 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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| Tislelizumab | Drug | Tislelizumab |
|
| Up to approximately 30 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 |
|---|---|
| C490954 | eribulin |
| C000707970 | tislelizumab |
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