Breast Cancer
Conditions
Interventions
Cohort A (SUVmax decline rate >=43%):Continue the original TIPy regimen for 4 cycles.
Cohort B (SUVmax decline rate <43%):Switch to TCbIPy regimen for 4 cycles
Sponsors
China-Japan Union Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and =50%; 5. ECOG performance status 0 or 1; 6. Organ function meets the following requirements without blood transfusion or symptomatic drug treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days before the first dose: - Blood routine: absolute neutrophil count (ANC) >=1.5×10^9/L; platelet (PLT) >=100×10^9/L; hemoglobin (Hb) >=90g/L; - Biochemistry: total bilirubin (TBIL) =50mL/min (Cockcroft-Gault formula); 7. Willing to participate in the study, sign the informed consent form, and have good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. History of previous invasive breast cancer; 2. Bilateral breast cancer, inflammatory breast cancer (e.g., erythema and/or skin involvement, and/or pathological finding of tumor cells in dermal lymphatic vessels), or clinical stage T1c, N0, M0; 3. Previous excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes; 4. Previous systemic treatment for breast cancer; 5. History of life-threatening hypersensitivity reactions, or known allergy to any component of the study drugs; 6. Participation in other drug or medical device clinical trials and receipt of investigational drugs or devices within 4 weeks before the first dose; 7. Receipt of major surgery within 28 days before the first dose, or planned major surgery during the study; 8. History of other malignant tumors within the past 5 years (except cervical in situ carcinoma, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ); 9. Active hepatitis, active tuberculosis, or other severe infectious diseases, including but not limited to: active HCV infection (excluding HCV antibody-positive but RNA-negative cases), or active HBV infection (HBsAg-positive with HBV-DNA copy number >2000 IU/mL), or severe infections requiring systemic treatment such as bacteremia or severe infectious pneumonia; 10. History of immunodeficiency or other autoimmune diseases, including but not limited to HIV infection (HIV antibody-positive), systemic lupus erythematosus, rheumatoid arthritis, or organ transplantation history; 11. History of the following cardiovascular and cerebrovascular diseases: (1) unstable angina; (2) arrhythmia requiring drug treatment or of clinical significance; (3) myocardial infarction within 6 months; (4) heart failure, grade II or higher atrioventricular block; (5) cerebral infarction (except lacunar infarction), intracerebral hemorrhage, etc., within 6 months; 12. Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite regular drug control), or history of hypertensive crisis or hypertensive encephalopathy; 13. Pregnant or lactating female patients; women of childbearing potential with a positive pregnancy test during screening; patients unwilling to use effective contraception throughout the trial and for 6 months after drug termination; 14. Other conditions deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response Rate (tpCR Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| tpCR Rate in Cohort A and Cohort B;Overall Response Rate (ORR);Event-Free Survival (EFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactWan Wang
Department of Breast Surgery, China-Japan Union Hospital of Jilin University
Outcome results
None listed