short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in triple-negative breast cancer

Conditions: Triple-negative Breast Cancer

Summary: the goal of this clinical trial is to learn about the efficacy and safety of short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in female early-stage triple-negative breast caner patients aging from 18 to 70 years with unilateral and invasive primary lesions above 1cm. the main questions it aims to answer are: 1. does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response (pcr) rates, objective response rates (orr), event-free survival (efs) and overall survival (os)? 2. does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term icis reported in literature? participants will be given 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin before surgery. an optional core-needle biopsy is performed after completing 2 cycles of sintilimab. all participants will be given regular follow-up post surgery according to asco guidelines.


Eligibility criteria:
inclusion criteria: 1. age: 18-70 years, female; 2. unilateral, invasive, primary breast cancer, t≥1cm, cn0-3, m0; 3. immunohistochemistry(ihc): er, pr\<10%; her-2 ihc "0", or ihc "+", or ihc "++" and fluorescence in situ hybridization (fish) negative; 4. at least one measurable lesion according to recist v1.1; 5. newly or recently-collected core needle biopsy specimen of the primary lesion available for pd-l1 status determination; 6. ecog score 0 or 1 within 10 days prior to drug administration; 7. currently not pregnant or breastfeeding, and meet at least one of the following conditions: 1. not women of childbearing potential (wocbps). 2. wocbps that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration. 8. organs well-functioned according to laboratory examination and imaging; 9. having good compliance with treatment plans, being capable of understanding the research process, and having signed a written informed consent. exclusion criteria: 1. bilateral invasive breast cancer or metastatic (stage iv) breast cancer; 2. with severe cardiovascular conditions: 1. myocardial infarction, acute coronary syndrome or pci/cabg within 6 months; 2. current nyha ii-iv congestive heart failure (chf) or past history of nyha iii-iv chf. 3. immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration; 4. active autoimmune diseases requiring systemic treatment within the past 2 years; 5. known history of active tuberculosis caused by bacillus tuberculosis; 6. history of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types; 7. severe systemic infections, or other serious illnesses; 8. history of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 9. known history of human immunodeficiency virus (hiv) infection; 10. active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection; 11. known allergy or intolerance to therapeutic drugs or their excipients; 12. history of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; 13. history of receiving anti pd-1, anti pd-l1, or anti pd-l2 drugs; or targeted drugs that act on stimulating or co-inhibitory t cell receptors (ctla-4, ox 40, cd137 etc.); 14. enrolled in a study of an investigational drug/instrument and given intervention within 4 weeks prior to drug administration for regular drugs/instruments and within 12 months for anticancer or anti-proliferative drugs/instruments; 15. live vaccine (including but not limited to the following: measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, bcg, typhoid vaccines, and nasal influenza vaccines such as flumist®) inoculation within 30 days prior to drug administration; 16. history of mental illness or drug abuse that may affect compliance with trial requirements; 17. during pregnancy or breastfeeding, or wocabs that refuse to adopt strict contraceptive measures; 18. deemed to be not appropriate for participating in this study by researchers.

Keywords: short-term sintilimab taxane carboplatin neoadjuvant therapy