HER2-positive breast cancer
Conditions
Interventions
Experimental Group:neteramab, Pertuzumab, Toripalimab and 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 years and 2cm, N+, and M0. 4. Her2-positive breast cancer refers to breast cancer confirmed by a pathological laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and positive in situ hybridization (ISH) test. 5. The organ function level requirements are as follows: Blood routine ANC>=1.5 × 10^9/L; PLT>=90× 10^9/L; Hb>=90g/L; Blood biochemical TBIL=50 mL/min (Cockcroft-Gault formula); Cardiac color Doppler ultrasound LVEF>=50%; The QT interval of the 12-lead electrocardiogram is less than 470ms. 6. Voluntarily join this study, sign the informed consent form, have good compliance and be willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, as well as those with the possibility of pregnancy, must take effective contraceptive measures. 2. ECOG score >=2; 3. Patients with distant metastasis; 4. The patient has a history of other malignant tumors in the past five years, including cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 5. Has ever suffered from any heart disease, including: arrhythmias that require medication or have clinical significance; Myocardial infarction Heart failure Any other heart diseases, etc. that the researcher judged as unsuitable for participating in this trial; 6. Any toxic reactions caused by previous anti-cancer treatments that have not yet been eliminated and exceed CTCAE2 grade; 7. Patients with severe uncontrolled concurrent infections or severe metabolic disorders; 8. Patients who are unwilling or unable to follow the protocol to continue the study, or who cannot cooperate with the follow-up; 9. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137); 10. Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study; The use of physiological doses of glucocorticoids (prednisone or equivalent drugs <=10mg/ day) is permitted; 11. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) has occurred within 2 years prior to the first administration. Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not regarded as systemic treatment; There is a history of non-infectious pneumonia requiring glucocorticoid treatment within one year before the first administration or there is currently interstitial lung disease. 12. Have received solid organ or blood system transplants; 13. There is a known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 14. Untreated active hepatitis B; Hepatitis B subjects who meet the following criteria are also eligible for inclusion: the HBV viral load must be less than 1000 copies /ml (200 IU/ml) before the first administration, and the subjects should receive anti-HBV treatment throughout the entire period of anti-tumor drug therapy to avoid viral reactivation. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring of viral reactivation is necessary. 15. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit) or those who have received a live vaccine within 30 days before the first administration (cycle 1, day 1); Note: Inactivated virus vaccine for injection against seasonal influenza is allowed to be administered within 30 days before the first dose. However, intranasal administration of attenuated live influenza vaccines is not allowed. 16. Those who the researchers consider unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival ,EFS ;Objective Response Rate, OR ;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactAnli Yang
Sun Yat-sen University Cancer Center
Outcome results
None listed