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This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer.
Eribulin: According to the standard dose,1.4mg/m^2 day1、8,repeated every 3 week. After 6 cycles, the investigator decided whether to continue treatment depending on the patient's tolerance.
Sintilimab: 500mg once every three weeks. The patients were treated until disease progression or intolerable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin Combined With Sintilimab | Experimental | Eribulin: 1.4mg/m^2 day1、8,repeated every 3 week. Sintilimab: 500mg once every three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | 1.4mg/m^2 day1、8,repeated every 3 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first. | up to 24 months |
| Clinical Benefit Rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients received blood transfusions ( platelets or red blood cells ) within 4 weeks before the initiation of treatment. 7.Patients received colony stimulating factors ( such as granulocyte colony stimulating factor [ g-CSF ], granulocyte macrophage colony stimulating factor or recombinant erythropoietin ) within 4 weeks before the start of treatment. 8.A history of platelet transfusion for chemotherapy-induced thrombocytopenia or prior cancer treatment (lasting > 4 weeks and associated with recent treatment) is known to result in ≥ grade 3 hematological toxicity. 9.The patient had any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 10.Patients have a severe, uncontrolled medical condition, a non-malignant systemic disease, or an active, uncontrolled infection. 11.Patients diagnosed, detected, or treated for another type of cancer within ≤2 years prior to beginning regimen therapy. 12.Patients with brain metastases or pial metastases uncontrolled. 13.Patients have received an allogeneic bone marrow transplant or double umbilical cord blood transplant. 14.Patients cannot swallow oral medications. 15.Patients with gastrointestinal disorders that may interfere with the absorption of investigational drugs. 16.Patients have had systemic active autoimmune disease (i.e., disease modulators, corticosteroids, or immunosuppressants) within the past two years.
17.Patients with a history of human immunodeficiency virus, active-hepatitis -B or C.
18.Pregnant or nursing women. Fertile adults without effective contraceptive methods.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Xi Shao, doctor | Contact | 15824113524 | 15824113524@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zhejiangCH | Hangzhou | Zhejiang | 310000 | China |
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| Sintilimab | Drug | 500mg once every three weeks. |
|
Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeksin the ITT analysis set.
| up to 24 months |
| Duration of Overall Response(DoR) | ime from first recording to CR or PR to disease progression or all-cause death. | up to 24 months |
| Time to response (TTR) | TR defined as the time from the date of the first dose of study treatment to the first objective tumor response when CR or PR is observed. | up to 24 months |
| Overall survival (OS) | Time to death from any cause from the date of first dose of study treatment | up to 24 months |
| adverse event(AE) | Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0. | Throughout the experiment, assessed up to 24 months. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| 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 |
| C000632826 | sintilimab |
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