Breast cancer, Brain metastases
Conditions
Interventions
Group A:SHR-A1811
Group B:SHR-A1811+Pertuzumab
Sponsors
Changde First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged =18 years; 2.Advanced breast cancer patients with positive HER-2 expression confirmed by pathology; ? Note: HER2 positivity refers to the presence of at least 3+ immunohistochemical staining or FISH positivity in the pathological examination/review of primary or metastatic lesions performed by the Department of Pathology of the participating hospitals. 3.MRI was used to diagnose the reported brain metastases 4.In the advanced stage, brain metastasis occurred during the treatment with pyrotinib-containing regimen or progressed after the treatment with pyrotinib-containing regimen 5.In the advanced stage, the number of treatment lines was =2 6.The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less. 7.Previous radiation therapy for brain metastases was allowed 8.The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, provided that the dose was stable for at least a week without the need for an increment. 9.The predicted survival time was =3 months. 10.Vital organ function was defined as: absolute neutrophil count (ANC) =1.5×109/L Platelet count =100×109/L (100,000/mm3) Hemoglobin (Hgb) =90g/L (9.0 g/dL) Albumin level, =3.0 g/dL Total bilirubin =1.5×ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN (=5×ULN in patients with liver metastases) Serum creatinine =1.5×ULN or creatinine clearance =60 mL/ minute (calculated according to the Cockcroft-Gault formula, Annex 4) Prothrombin time (PT) and activated partial thromboplastin time (APTT) =1.5×ULN QTcF=470 msec Echocardiography (ECHO) or cardiac radionuclide scan (MUGA) shows left ventricular ejection fraction (LVEF) =50%. 11.Patients or their legal representatives provided consent and signed informed consent and were willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1.Brain metastasis patients with extensive leptomeningeal metastasis and poor response to hormone dehydration treatment; 2.The presence of third-space fluid collection (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods; 3.Patients who received chemotherapy, major surgery or molecular targeted therapy within 4 weeks before enrollment; Patients received endocrine therapy within 2 weeks before enrollment. Chemotherapy with nitrosourea or mitomycin was administered within 6 weeks before enrollment. 4.Participated in other clinical trials of new drugs within 4 weeks before enrollment; 5.had previously received anti-HER2-ADC containing a topoisomerase I inhibitor 6.Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 7.The exceptions were concomitant use of any other antineoplastic therapy, bevacizumab for the control of brain edema and bisphosphonates for the treatment of bone metastases or the prevention of osteoporosis. 8.Patients who had used immunosuppressive or systemic hormonal therapy for immunosuppression within 2 weeks before the first dose (prednisone at a dose of >10 mg per day or another corticosteroid at the pharmacologic physiological dose) did not include nasal spray or inhaled corticosteroids 9.Patients have any active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (those controlled only with hormone replacement therapy are eligible); Subjects with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely resolved in childhood and without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded. 10.A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. 11.The presence of clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure (NYHA class = II), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first dose of medication, or cerebrovascular accident (including transient ischemic attack)." 12.Uncontrolled hypertension (resting systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); 13.Pregnant, lactating, fertile women who had a positive pregnancy test at baseline, or women of childbearing age who were unwilling to use effective contraception throughout the trial. 14.Subjects with known or suspected interstitial pneumonia; Other moderate to severe pulmonary diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function within three months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive pulmonary disease, etc. "And any autoimmune, connective tissue, or inflammatory disease with lung involvement,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IC-ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;IC-PFS; | — |
Countries
China
Contacts
Public ContactWutao
Changde First People's Hospital
Outcome results
None listed