Patients with histologically confirmed operable triple-negative invasive breast cancer (T1cN1-2 or T2-4N0-2) with percentage of tumor-infiltrating lymphocytes >10% in baseline breast tumor.
Conditions
Interventions
Treatment:Neoadjuvant therapy
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients sign the written informed consent. 2.Women aged 18-70. 3.Patients with histologically confirmed operable invasive breast cancer (T1cN1-2 or T2-4N0-2)[ER-negative(IHC10% in baseline breast tumor. 5.Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard. 6.No previous breast cancer-related treatment, including chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy. 7.Patients can swallow pills. 8.Eastern Cooperative Oncology Group (ECOG) performance status of =90g/L; • Plt>=100^9/L; • Serum albumin >=g/dL; • Neutrophils>=1.5^9/L; • TSH=60mL/min. 12.Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1.Combination of other malignancies or previous malignancies other than breast cancer within the last 5 years, except for basal cell carcinoma or flat cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been adequately controlled by treatment; 2.Those who are not suitable for immunotherapy in combination with active infection; 3.The combination of severe non-malignant disease that would affect patient compliance or put the patient at risk; 4.Concomitant with other antineoplastic therapy or are participating in other clinical trials; 5.Male breast cancer, bilateral breast cancer or inflammatory breast cancer; 6.Patients with dementia, mental abnormality or any mental illness that prevents understanding of the informed consent form; 7.Patients with history of allergic reaction or contraindication to the use of any drug component of this trial; 8.Patients with any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; 9.subjects with vitiligo or whose asthma has completely resolved in childhood and does not require any intervention in adulthood may be included; 10.(Patients with asthma that requires medical intervention with bronchodilators cannot be included); 11.Have cardiac clinical symptoms or disease that are not well controlled, such as: (1) NYHA class 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 12.Urine routine suggestive of urine protein >=++, or confirmed 24-hour urine protein amount >=1.0g; 13.Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 14.Patients with congenital or acquired immune deficiencies (e.g., HIV-infected individuals); 15.Live vaccines administered less than 4 weeks prior to study drug administration or possibly during the study; 16.Active tuberculosis; 17.Patients have received oral or intravenous antibiotic therapy within 2 weeks prior to neoadjuvant therapy; 18.Major surgical procedure within 4 weeks prior to the start of study treatment or anticipated need for major surgical procedure during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Remission (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Breast Conservation Rate;Overall Survival;Incidence of Treatment-Emergent Adverse Events;Frequencies of Biomarkers;Event-Free Survival; | — |
Countries
China
Contacts
Public ContactJieqiong Liu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed