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To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin in combination with anti-PD-1 antibody | Experimental | Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Eribulin Mesylate,1.4mg/m2,Intravenous infusion,d1,d8,3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival,PFS | The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Adverse Events are monitored throughout the trial and for 30 days after discontinuation of treatment (90 days for serious adverse events) and graded according to the Common Terminology Criteria for Adverse Events, version 4.0, of the National Cancer Institute. | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months |
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Inclusion Criteria:
The patients sign the written informed consent.
Women aged 18-75.
The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)]. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
PD-1/PD-L1positive or TMB≥5.
Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
The results of patient's blood tests are as follows:
• Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaobo wang, doctor | Contact | +86-010-66947250 | 724292466@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | 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 |
|---|---|
| C490954 | eribulin |
| C000711728 | spartalizumab |
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| anti-PD-1 antibody | Drug | Sintilimab Injection,Intravenous infusion,200mg,3-week cycle |
|
| the correlation between the expression of PD-L1 of circulating tumor cells and prognosis | To detect the differences of the expression of PD-L1 in patients with different curative effects and prognosis,including the number of circulating tumor cells,and PD-L1 expression or others. | From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |