breast cancer
Conditions
Interventions
1:TCH + IFN ?
2:TCH
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Histopathological and immunohistochemical diagnosis of HER2-positive breast cancer in women, any ER, PR status; (2) Aged 18 to 70 years old; (3) Breast cancer patients with stage II a-III c plan for neoadjuvant therapy; (4) The size of tumors can be assessed. (5) KPS physical condition score (>70); (6) Adequate bone marrow functional reserve: total white blood cells (>4.0 *109/L), neutrophils (>2.0 *109/L), platelets (>100 *109/L), hemoglobin (>90 g/L); (7) Serum creatinine 44-133 mol/L; (8) The upper limit of AST and ALT is less than 2 * normal value, alkaline phosphatase is less than 2 * normal value, and bilirubin is less than normal value; (9) LVEF >50%; (10) The expected survival time is more than 12 months; (11) Pregnancy tests for women of childbearing age must be negative, and patients and their spouses should agree to use effective contraceptive measures during treatment and in the following year; (12) Sign the informed consent. Note: Because of consciousness disorder, upper limb paralysis or inability to write, the legal agent will sign the informed consent when the subject is unable to sign it.
Exclusion criteria
Exclusion criteria: (1) New York Heart Association (NYHA) scores identified patients with heart disease at grade II or above; (2) Severe systemic infection; (3) Known to be allergic, highly sensitive or intolerable to taxanes, carboplatin, Herceptin or interferon gamma excipients; (4) Within 30 days before the first dose of the research drug was given, any experimental drug, radiotherapy or other chemotherapeutic drugs were used. (5) In the opinion of the researchers, participating in the experiment is not in the best interests of the subjects (e.g. endangering their health) or in any circumstances that may hinder the evaluation of the test program; (6) Uncontrolled cross-diseases include, but are not limited to, persistent or active infections, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric/social conditions that limit compliance with learning requirements; (7) Currently, corticosteroids are used to treat prednisone > 5 mg/day or other corticosteroids at the same dose (local, intranasal, inhaled corticosteroids, standard dose and physiological replacement for patients with adrenal insufficiency); (8) Pregnancy or lactation; (9) Known HIV positive; (10) The known history of current or hepatitis B or C viruses, including chronic and dormant states, unless the disease is treated and confirmed; (11) Major operations were performed within four weeks of starting drug research. (12) The second aggressive malignant tumor needs active treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective remission rate, CR+PR), Response rate of primary tumors with MP grade of 4-5; rate of adverse events; DFS; OS; | — |
Contacts
Public ContactYunjiang Liu
The Fourth Hospital of Hebei Medical University
Outcome results
None listed