HER2-positive breast cancer
Conditions
Interventions
The group of Intervention :inetetamab combined with pertuzumab, toripalimab, and albumin-bound paclitaxel
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 and 2cm, N+, M0 based on the AJCC Cancer Staging Manual (8th Edition) and systemic imaging. 4. HER2-positive breast cancer, defined as: - IHC score 3+ and/or - IHC 2+ with positive in situ hybridization (ISH) (confirmed by local pathology laboratory). 5. Adequate organ function: - Hematology: ANC >=1.5×10^9/L; PLT >=90×10^9/L; Hb >=90 g/L. - Biochemistry:TBIL =50 mL/min (Cockcroft-Gault formula). - Cardiac function:LVEF >=50% (by echocardiography); QTc interval <470 ms (12-lead ECG). 6. Voluntary participation, signed informed consent, good compliance, and willingness to follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breastfeeding, or of childbearing potential not using effective contraception. 2. ECOG performance status >=2. 3. Patients with distant metastasis. 4. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. 5. History of any cardiac disease, including: - Clinically significant arrhythmia requiring medication; - Myocardial infarction; - Heart failure; - Any other cardiac condition deemed unsuitable by the investigator. 6. Persistent toxicities (>CTCAE Grade 2) from prior anticancer therapy. 7. Uncontrolled concurrent infections or severe metabolic disorders. 8. Patients unwilling or unable to comply with the study protocol or follow-up. 9. Prior therapy with: - Anti-PD-1, anti-PD-L1, or anti-PD-L2 agents; - Drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137). 10. Diagnosis of immunodeficiency or systemic glucocorticoid therapy (>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 7 days prior to the first dose (physiologic glucocorticoid doses permitted). 11. Active autoimmune disease requiring systemic treatment within 2 years before the first dose (e.g., disease-modifying agents, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal/pituitary insufficiency) is allowed. - History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current interstitial lung disease. 12. History of solid organ or hematopoietic stem cell transplantation. 13. Known HIV infection (HIV 1/2 antibody-positive). 14. Untreated active hepatitis B. - Exception:HBV DNA <1000 copies/mL (200 IU/mL) at screening, with antiviral therapy during the study. - HBV carriers with undetectable viral load (anti-HBc+, HBsAg-, anti-HBs-) require close monitoring but no prophylaxis. 15. Active HCV infection (HCV antibody-positive with detectable HCV-RNA) or live vaccination within 30 days before the first dose. - Exception:Inactivated seasonal influenza vaccines are permitted. 16. Any other condition deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total Pathological Complete Response; | — |
Countries
China
Contacts
Public ContactAnli,YANG
Sun Yat-sen University Cancer Center
Outcome results
None listed