Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial

NeoSTEP

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.

2023-07-01

2024-12-31

2034-12-31

Not yet recruiting

Early phase I

48

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2023-06-06