Breast Cancer
Conditions
Interventions
Eribulin combined with Sintilimab group:Eribulin: According to the standard dose,1.4mg/m^2 day1, 8, repeated every 3 week. After 6 weeks, the researcher will decide whether to continue treatment based
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient has been fully informed of the nature of the study and voluntarily joined the study, signing an informed consent form. 2. Women aged 18 years or older. 3. Eastern Cooperative Oncology Group(ECOG) has a physical fitness score of 0 or 1. 4. Life expectancy is more than six months. 5. Diagnosed as HER2-negative metastatic breast cancer, defined as: human epidermal growth factor receptor 2 (HER2) immunohistochemical staining is negative, HER2 immunohistochemical (IHC) results are 0, 1+, if IHC 2+, in situ hybridization (ISH) results should be negative. 6. There was at least one measurable lesion according to RECIST 1.1. 7. Patients with HR-positive HER2-negative metastatic breast cancer received first-line endocrine therapy, including endocrine therapy alone or in combination with a CDK4/6 inhibitor. 8. In the neoadjuvant or adjuvant stage, patients who had received treatment with anthracyclines or taxanes had recurrence or metastasis more than 6 months after the last administration. 9. Patients who are HR-positive can receive first-line endocrine therapy. 10. Good organ function, including: Neutrophil count = 1500/µ L (growth factor support therapy should not be used within 7 days of the start of study treatment). Platelets = 100000/µ L (platelet input and any form of platelet elevation therapy are not allowed within 2 weeks of the start of the study). Hemoglobin = 90g/L (blood transfusion is not allowed within 2 weeks of the start of study treatment, and EPO support treatment is required within 7 days). Serum creatinine = 1.5 times the upper limit of normal value, or creatinine clearance rate = 60mL/min (calculated according to Cockcroft Gault formula). Total bilirubin = 1.5 times the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of normal value. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5 times the upper limit of normal values, and in the presence of liver metastasis, they must be = 5 times the upper limit of normal values. Urinary protein = (+), or 24-hour urine protein quantification less than 1g. International standardized ratio (INR) or prothrombin time (PT) = 1.5ULN, unless the patient is undergoing anticoagulant treatment and the PT or partial thromboplastin time (PTT) is within the expected range of anticoagulant treatment. Activated partial thromboplastin time = 1.5ULN, unless the patient is receiving anticoagulant treatment, PT or PTT is within the expected range of anticoagulant treatment. 11. Fertile female patients must have a negative serum pregnancy test within seven days prior to study treatment and consent to effective contraceptive use for 180 days from screening to the last dose of study treatment. 12. Female patients must agree not to breastfeed during the study period or for 180 days after the last dose of study therapy.
Exclusion criteria
Exclusion criteria: 1. In the metastatic stage, previous use of Eribulin or immunotherapy or other drug chemotherapy. 2. Patients enrolled in any interventional clinical trial at the same time and received the investigational therapy = four weeks prior to initiation of the regimen or at least five half-lives of the investigational drug. 3. Patients who had received radiation therapy with bone marrow coverage >20% within two weeks before the start of treatment, except for minor palliative radiation therapy more than one week before the first day of the study. 4. Patients with a visceral crisis, and requiring chemotherapy. 5. Patients allergic to Eribulin or Sintilimab. 6. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Clinical Benefit Rate;Duration of Response;Time to response;Overall survival ;Adverse event; | — |
Countries
China
Contacts
Public ContactXiying Shao
Zhejiang Cancer Hospital
Outcome results
None listed