Breast cancer
Conditions
Interventions
experimental group:Radiotherapy was followed by Adebrelimab and apatinib
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Women >=18 years old, 10% tumor cells positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative); 3) Locally advanced breast cancer (no radical local treatment) or recurrent metastatic breast cancer; 4) HR+/HER2- advanced breast cancer patients with >2 lines of endocrine therapy, and at least 1 line of endocrine therapy combined with CDK4/6 inhibitors are allowed to receive =1 line of chemotherapy; 5) Have at least two lesions according to RECIST version 1.1, of which at least one is measurable (conventional CT >=20 mm, spiral CT >=10 mm, measurable lesion has not received radiotherapy) and the other is suitable for radiotherapy (can be a non-measurable lesion such as bone metastasis); 6) The functions of the main organs are basically normal, and the following conditions are met: ? The standard of blood routine examination should meet: HB >=90 g/L (no blood transfusion within 14 days); ANC >=1.5×109 /L; PLT >=75×109 /L; ? Biochemical examination should meet the following criteria: TBIL = 5×ULN; Serum Cr 50 ml/min (Cockcroft-Gault formula); 7) have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation, and have recovered from acute toxic effects of prior treatment (except for alopecia or grade I peripheral neurotoxicity; If surgery is performed, the wound has completely healed); 8) ECOG score =3 months; 9) Fertile female subjects are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; 10) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Any of the following circumstances will not be accepted as a subject: 1) Radiotherapy, chemotherapy, immunotherapy, except bisphosphonate (for bone metastases) were used 3 weeks before treatment; 2) A history of clinically important or uncontrollable heart disease, including congestive heart failure, heartache, myocardial infarction within the last 6 months, or ventricular arrhythmia; 3) Symptomatic pulmonary embolism or hypertension poorly controlled by standard antihypertensive drugs occurred 10 mg prednisone daily equivalent) or other immunosuppressants within 2 weeks prior to initial use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses > 10mg/ day of prednisone efficacy are permitted; 10) Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug; 11) Have an active autoimmune disease, a history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, including but not limited to these diseases or syndromes), an immune deficiency disease (including HIV testing positive, or other acquired, congenital immunodeficiency diseases), Or have a history of organ transplantation and allogeneic bone marrow transplantation); 1. Patients with the following diseases do not need to be excluded and can be further screened: 2. Type I diabetes is well controlled with stable dose insulin; 3. Autoimmune-mediated hypothyroidism treated with stable dose thyroid replacement hormone; 4. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia); 5. Patients who have recovered from childhood asthma/allergies and do not require any intervention as adults (asthma patients who require medical intervention with bronchodilators are not included); 6. Celiac disease that can be controlled by diet alone; 7. Any other disease that is not expected to recur in the absence of external triggers. 12) Subjects with active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of assay) 13) Prior antibody or drug therapy against PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin mucin domain molecule 3 (TIM-3), LAG-3, or any other specific targeting of T-cell co-stimulation or immune checkpoint pathways. 14) symptomatic visceral metastases that are advanced/metastatic and at risk of rapidly evolving into life-threatening complications, Such as metastatic lung cancer lymphangitis, bone marrow metastasis, cancerous meningitis, liver metastasis with obvious symptoms, shortness of breath requiring oxygen, symptomatic pleural effusion requiring oxygen,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CBR;OS; | — |
Countries
China
Contacts
Public ContactGanlu
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed