Triple Negative Breast Cancer
Conditions
Interventions
Test group:Cadonilimab combined with chemotherapy
Sponsors
Changde First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily enrolled in the study, signed an informed consent form, and were compliant; 2. Age: 18-75 years (at the time of signing the informed consent form); ECOG PS score: 0-1; expected survival more than 6 months; 3. Patients with primary breast cancer confirmed by pathologic histology or cytology; 4. Laboratory tests confirm the diagnosis as HER2 negative; Note: Definition of HER-2 negative: immunohistochemistry results of 0, 1+, 2+ and FISH double probe negative (2018 edition of ASCO/CAP HER2 testing guidelines); 5. Confirm that both estrogen receptor [ER] and progesterone receptor [PgR] are negative; 6. The patient agrees to undergo mastectomy for breast cancer when surgical criteria are met after neoadjuvant therapy; 7. Invasive breast cancer that, in the judgment of the investigator, meets the American Joint Committee on Cancer AJCC 8th edition TNM staging for breast cancer, stage IA-IIIC (T1c-T4 plus any N, M0) and histologically confirmed invasive breast cancer; patients with invasive breast cancer must have a solid lesion capable of coarse needle aspiration biopsy. 8. Major organs are functioning well and meet the following criteria: (1) Criteria for routine blood tests (no blood transfusion or correction with hematopoietic-stimulating factor analogs within 7 days prior to screening): 1) Hemoglobin (HGB) >= 90 g/L; 2) Absolute neutrophil value (NEUT) >=1.5 x 10^9 /L; 3) Platelet count (PLT) >= 100 x 10^9 /L; 4) Leukocytes >= 2.5 x 10^9 /L. (2) Biochemical tests need to meet the following criteria: 1) Total bilirubin (TBIL) = 50 ml/min. (3) Coagulation tests need to meet the following criteria: 1) Prothrombin time (PT), activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) = 1.5 x ULN (no anticoagulant therapy) if the patient is on anticoagulant therapy as long as the PT is within the range of anticoagulant medication proposed to be used; 9. For women who are not menopausal (menopause defined as non-treatment-induced menopause = 12 months) or who are not surgically sterilized (removal of ovaries and/or uterus): consent to use non-hormonal contraception with an annual failure rate of < 1%, either singly or in combination, for the duration of the treatment period and at least 7 months after the last study treatment is required; 10. Women of childbearing age, with premenopausal or postmenopausal menopause of less than 12 months, who have not been surgically sterilized, and who have a negative serum pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Stage IV metastatic breast cancer or other patients who, in the judgment of the investigator, cannot achieve radical surgical resection with neoadjuvant therapy; 2. Bilateral invasive breast cancer; 3. Breast cancer patients with prior anti-tumor therapy, such as chemotherapy, endocrine therapy, or anti-HER2 biologic therapy, or who have undergone breast surgery (except for diagnostic biopsies for primary breast cancer); 4. Presence of or current concurrent other malignancies within 3 years. Two of the following are eligible for enrollment: other malignancies treated with a single surgical procedure to achieve 5 consecutive years of disease-free survival (DFS); cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane)]; 5. Major surgical treatment, incisional biopsy, or significant traumatic injury (other than diagnostic biopsy for primary breast cancer) within 28 days prior to the start of study treatment; 6. Long-standing unhealed wounds or fractures; 7. Any of the following cardiovascular diseases (1) Myocardial infarction, unstable angina, pulmonary embolism, aortic coarctation, deep vein thrombosis, and any arterial thromboembolic event in the 6 months prior to randomization; (2) Heart failure with a New York Heart Association (NYHA) cardiac function class >= II; (3) Presence of severe arrhythmias requiring long-term pharmacological intervention; enrollment of patients with asymptomatic, ventricular rate-stabilized atrial fibrillation is permitted; (4) Cerebrovascular event (CVA) within 6 months prior to randomization; (5) Left ventricular ejection fraction (LVEF) 150 mmHg and diastolic blood pressure >100 mmHg) despite adequate antihypertensive medication, or a history of hypertensive crisis, hypertensive encephalopathy. 8. Persons with a history of psychotropic substance abuse that cannot be withdrawn or who are mentally challenged; 9. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (hepatitis B surface antigen [HBsAg]-positive with HBV DNA >1000 IU/mL), and active viral hepatitis C subjects; Note: Inactive or asymptomatic carriers, treated and stable subjects with hepatitis B meeting HBV DNA <=1000 IU/mL are allowed to enroll. Cured subjects with viral hepatitis C, HCVAb-positive and HCV RNA-negative subjects are allowed to enroll. 10. Human Immunodeficiency Virus (HIV) infection or known to have Acquired Immune Deficiency Syndrome (AIDS); 11. Active syphilis infection; 12. Received treatment with proprietary Chinese medicines with anti-tumor indications as specified in the NMPA-approved drug inserts (including Compound Zebu Capsules, Kang'ai Injection, Kang'ai Capsules/Injection, Ai Di Injection, Crow's berry oil injection/capsules, Cancer elimination tablets/injection, Huazhuanin Capsules, etc) within 2 weeks prior to the commencement of study treatment; 13. Those whose imaging (CT or MRI) shows that the tumor has invaded important blood vessels or who, in the judgment of the investigator, have a high likelihood of fatal hemorrhage due to tumor invasion of important blood vessels during the follow-up study; 14.Active autoimmune disease requiring systemic therapy (e.g., use of palliative medications, c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| breast pathological complete response rate;breast-conserving surgery rate;Objective Response Rate;Event-free survival;Disease-free survival;Overall Survival;safety; | — |
Countries
China
Contacts
Public ContactWu Tao
Changde First People's Hospital
Outcome results
None listed