Triple-negative breast cancer (TNBC)
Conditions
Interventions
Intervention group:Iparomlimab and Tuvonralimab Injection (QL1706) ,Anlotinib,Albumin-bound Paclitaxel, Carboplatin
1. Epalorlimo Voririlimab: 5mg/kg, intravenous infusion, administered once every 3
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins this study, signs the informed consent form, and has good compliance. 2. Age: 18–75 years old (at the time of signing the informed consent form). 3. ECOG PS score: 0–1. 4. Expected survival >6 months. 5. Patients with histologically or cytologically confirmed invasive breast cancer. 6. Laboratory-confirmed HER2-negative status. Note: HER-2 negativity is defined as immunohistochemistry results of 0, 1+, or 2+ with FISH dual-probe negative (according to the 2018 ASCO/CAP HER2 Testing Guidelines). 7. Both estrogen receptor (ER) and progesterone receptor (PgR) are confirmed negative. 8. The patient agrees to undergo breast cancer resection surgery when surgical criteria are met after neoadjuvant therapy. 9. As judged by the investigator, the patient meets the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria for stage II–IIIC (T2–T4 with any N, or any T with N1–3, M0) and has histologically confirmed invasive breast cancer, and the patient must have a solid lesion amenable to core needle biopsy. 10. Adequate major organ function, meeting the following criteria: 11. (1) Hematological criteria (without blood transfusion or use of hematopoietic growth factors within 7 days prior to screening): 1) Hemoglobin (HGB) >=90 g/L; 2) Absolute neutrophil count (NEUT) >=1.5×10^9/L; 3) Platelet count (PLT) >=100×10^9/L; 4) White blood cell count >=2.5×10^9/L; (2) Biochemical criteria: 1) Total bilirubin (TBIL) =50 mL/min; (3) Coagulation criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) =12 months) or not surgically sterile (bilateral oophorectomy and/or hysterectomy): they must agree to use a single or combined non-hormonal contraceptive method with a failure rate of <1% per year during the treatment period and for at least 7 months after the last study treatment. 12. Women of childbearing potential, premenopausal women, or postmenopausal women with <12 months of amenorrhea and not surgically sterile must have a negative serum pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Stage IV metastatic breast cancer, or other conditions judged by the investigator as not amenable to curative surgical resection through neoadjuvant therapy. 2. Bilateral invasive breast cancer. 3. Prior anticancer treatment, such as chemotherapy, immunotherapy, or targeted therapy, or prior breast surgery for breast cancer (except for diagnostic biopsy of the primary breast cancer). 4. Presence or history of other malignancies within 3 years. The following two conditions are eligible for enrollment: other malignancies treated with surgery alone and achieving a disease-free survival (DFS) of >=5 years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]. 5. Major surgical procedure, open biopsy, or significant traumatic injury (except for diagnostic biopsy of the primary breast cancer) within 28 days before the start of study treatment. 6. Long-standing unhealed wounds or fractures. 7. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 8. History of substance abuse (psychoactive drugs) that cannot be abstained from, or psychiatric disorders. 9. Subjects with any severe and/or uncontrolled diseases, including: (1) History of hypertensive crisis or hypertensive encephalopathy; or uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg despite antihypertensive medication); (2) History of heart failure or systolic dysfunction (LVEF = Grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc >=450 ms for males, QTc >=470 ms for females), and >= Grade 2 congestive heart failure (New York Heart Association [NYHA] classification); (4) Angina requiring anti-anginal therapy; (5) Clinically significant valvular heart disease; (6) Positive results at screening for HCV antibody, HIV antibody, Treponema pallidum-specific antibody, or HBsAg with peripheral blood HBV DNA titer above the normal range. 10. Use of NMPA-approved traditional Chinese medicines with clear anti-tumor indications (including Fufang Banmao Capsule, Kangai Injection, Kanglaite Capsule/Injection, Aidi Injection, Yadanzi Oil Injection/Capsule, Xiaoaiping Tablet/Injection, Huachansu Capsule, etc.) within 2 weeks before the start of study treatment. 11. Imaging (CT or MRI) showing tumor invasion of major blood vessels, or judged by the investigator as having a high risk of tumor eroding major blood vessels and causing fatal hemorrhage during the subsequent study period. 12. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years before the start of study treatment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 13. Diagnosis of immunodeficiency, or current systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10 mg/day prednisone or equivalent), and continued use within 2 weeks prior to the first dose. 14. Other comorbidities that may interfere with the planned treatment, including severe pulmonary dysfunction/disease, ac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year Progression-Free Survival;Objective Response Rate (ORR);Safety;Breast-conserving rate;2-year Overall survival (OS);Breast pathological complete response rate (bpCR); | — |
Countries
China
Contacts
Public ContactChen Jianbo
The First Affiliated Hospital of Xiamen University
Outcome results
None listed