Patients with metastatic or recurrent advanced triple-negative, endocrine-resistant, or primary/acquired resistant HER2-positive breast cancer confirmed by histology or cytology
Conditions
Interventions
Experimental group:Sintilimab combined with hypofractionated radiotherapy treatment
Sponsors
Liuzhou people's hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Before implementing any trial-related procedures, sign a written informed consent; 2.Ages >=18 years old and 2-line systemic therapy for recurrent/metastatic disease stages, including chemotherapy, other targeted therapies, or other investigational anti-tumor therapies; 7. Subjects with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed; 1) Measurable lesions outside the central nervous system; 2) no glucocorticoid therapy is required, or glucocorticoid therapy is discontinued within 7 days prior to the first dose, or glucocorticoid dosage is stable and reduced to less than 10mg/day prednisone (or equivalent) within 7 days prior to the first dose; 8.Subjects are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases) provided that the radiation therapy is terminated at least 1 week prior to the first dose and that the radiotherapy-related toxicity has recovered to less than or equal to 1 grade (CTCAE 5.0, with the exception of alopecia); 9. ECOG score 0-1 points; 10.Expected survival time > 3 months; 11. Sufficient organ function, subjects need to meet the following laboratory indicators; 10). In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) >=1.5×10^9/L; 11) Platelet >= 100×10^9/L without blood transfusion in the past 14 days; 12) Hemoglobin > 9g/dL without blood transfusion or erythropoietin use in the past 14 days; 13) Total bilirubin <=1.5× upper limit of normal (ULN); 14) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) in <=2.5× ULN (s
Exclusion criteria
Exclusion criteria: 1.Individuals who have undergone major surgery within 4 weeks prior to enrollment or are expected to undergo major surgery during the trial; or those who have received adjuvant chemotherapy within 4 weeks prior to enrollment; or those who have received radiotherapy within 2 weeks prior to enrollment; or those who have received other antitumor treatments for recurrent/metastatic breast cancer within 2 weeks prior to enrollment; 2.Symptomatic known brain metastases or other CNS metastases; 3.Received radiotherapy within 4 weeks before treatment with a dose greater than 30Gy; 4.Diagnosed with other malignant diseases, excluding breast cancer, within 5 years prior to the first administration of medication. 5.Individuals who participated in other clinical trials within 4 weeks prior to enrollment, or who received other investigational drugs or underwent treatment with investigational medical devices within 4 weeks before the first administration of the study medication; those who failed the screening for clinical trials are excluded; 6.Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor; 7.Received traditional Chinese medicine with indications for breast cancer or drugs with immunomodulatory effects within 2 weeks before the first administration of the study medication; 8.eceived any of the following therapies before: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (for example, CTLA-4, OX-40, CD137) within 2 weeks before the first administration of the study drug; or received traditional Chinese medicine with anti-breast cancer indications or drugs with immunomodulatory effects within 2 weeks before the first administration of the study drug; 9.Active autoimmune diseases within 2 years prior to the first dose that required systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants); 10.Within 7 days prior to the first administration of the study medication, individuals are receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy; 11.The presence of clinically uncontrollable pleural effusion/ascites; 12.Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13.Individuals known to be allergic to the active ingredients or excipients of the study drugs, such as sintilimab, eribulin, gemcitabine, capecitabine, etc; 14.Prior to the start of treatment, there has not been adequate recovery from any toxicities and/or complications caused by any intervention; 15.Known history of Human Immunodeficiency Virus (HIV) infection; 16.Active untreated hepatitis B; 17.Active HCV infection; 18.Received live vaccines within 30 days prior to the first administration of the study medication; 19. Presence of any severe or uncontrollable systemic disease; Resting ECG has significant abnormalities in rhythm, conduction, or morphology that are severe and difficult to control, Such as complete left bundle branch block, heart block above the second degree, ventricular arrhythmias, or atrial fibrillation; 2) unstable angina, congestive heart failure, New York Heart Association (NYHA) classification >= grade 2 chronic heart failure; 3) myocardial infarction within 6 months prior to treatment; 4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS,progression-free survival;AE,Adverse events;DCR,Disease control rates;DOR,Duration of remission;OS,overall survival;Incidence of serious adverse events (SAEs);Incidence of AEs/SAEs leading to treatment discontinuation; | — |
Countries
China
Contacts
Public ContactQin Jianing
Liuzhou people's hospital
Outcome results
None listed