breast cancer
Conditions
Interventions
test group:radiotherapy in combination with TQB2450 and anlotinib hydrochloride
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study and sign informed consent; 2. Females aged = 18 years; 3. Pathologically confirmed recurrent metastatic HER2-negative breast cancer (HER2-negative IHC-/+ or IHC++ but FISH/CISH-) with at least 1 measurable lesion that meets RECIST v1.1 criteria; 4. Previous treatment with anthracyclines and/or Taxanes (including neoadjuvant, adjuvant, metastatic stage), and the number of chemotherapy lines in the recurrent metastatic stage = 1 line; 5. Patients who are positive for hormone receptor (ER positive (IHC ER positive percentage=1%), PR positive (IHC PR positive percentage =1%)) have previously received =1-line endocrine therapy 6. Able to swallow tablets; 7. ECOG score: 0~1; 8. Expected survival= 12 weeks; 9. After evaluation by radiotherapy experts, at least one tumor lesion is suitable for radiotherapy; 10. Adequate control of blood pressure; 11. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening): absolute neutrophil count= 1.5×109/L; platelets= 100×109/L; hemoglobin= 9g/dL; serum albumin= 3 g/dL; Thyroid-stimulating hormone (TSH) = ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be enrolled); bilirubin = 1.5 times ULN; ALT and AST =2.5 times ULN; AKP= 2.5 times ULN; Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min
Exclusion criteria
Exclusion criteria: 1. Women of pregnancy or lactation (women of childbearing age must have a negative pregnancy test within 14 days before the first dose, if positive, pregnancy needs to be ruled out by ultrasound), women of childbearing age who are unwilling to take effective contraception during the study; 2. Patients with a history of prior breast cancer are excluded, except for ipsilateral DCIS that received only local therapy = 5 years ago. Patients with a history of any other cancer (other than non-melanoma skin cancer or carcinoma in situ of the cervix) are excluded unless the patient's tumor has been completely remission and has not been treated for at least 5 years prior to the date of enrollment; 3. Have participated in any investigational drug treatment within 4 weeks prior to the start of treatment; 4. Previous reception of any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy. Previous targeted therapy with anti-VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways; 5. Subject with clinical symptoms of central nervous system metastases. Patients with stable asymptomatic brain metastases who have already received radiotherapy with at least one evaluable target lesion in addition to brain metastases may be enrolled, but at least 4 weeks after the last radiotherapy; 6. Patients who have developed bone metastasis who have received axial bone radiotherapy within four weeks before the start of the study or the toxicity caused by previous radiotherapy has not recovered; 7. Major surgery was performed within 4 weeks before enrollment, or the surgical wound has not healed; 8. Embolism and bleeding events within 4 weeks before enrollment; 9. Severe cardiovascular disease, including hypertension (BP= 160/95mmHg) that cannot be controlled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure, > NYHA grade II, severe arrhythmias, and pericardial effusion; 10. Severe infections requiring intravenous antibiotics, antifungal or antiviral therapy; 11. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first administration. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Only patients who are positive for autoimmune antibodies should confirm the presence of autoimmune disease according to the investigator's judgment; 12. Have used immunosuppressive drugs within 4 weeks before the first dose, excluding nasal spray, inhalation or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10mg/day prednisone or equivalent doses of other glucocorticoids), allowing temporary use of glucocorticoids due to the treatment of asthma, chronic obstructive pulmonary disease and other respiratory symptoms; 13. Known hypersensitivity to any TQB2450, anlotinib preparation ingredients; or previous severe allergic reactions to other monoclonal antibodies or tyrosine kinase inhibitors; 14. Suffering from mental illness and poor compliance; 15. The investigators did not consider enrollment appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Clinical benefit rate;Duration of remission;time to remission;12-month overall survival rate; | — |
Countries
China
Contacts
Public ContactLi Xie
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed