Study design and patients
basal cell carcinoma of the skin), tumor, Tumor, non-metastatic (stage IIA-IIIC, TNBC, malignant diseases, Cancer
TUMOR, METASTASIS, TUMOR, MALIGNANT DISEASE, CERVICAL CARCINOMA IN SITU, ONCOLOGY, METASTATIC BREAST CANCER, CANCER
This investigator-initiated single-arm, open-label, phase II trial was conducted at the Affiliated Cancer Hospital of Zhengzhou University in China. The study was performed in compliance with the Good Clinical Practice guideline and Declaration of Helsinki (revised in 2013). The study protocol and any amendments were approved by Institutional Review Board of the Affiliated Cancer Hospital of Zhengzhou University (Ethics number: 2019110712). All patients provided written informed consent before participation. No participation compensation was provided. The trial was registered with ClinicalTrials.gov (NCT04213898) on December 27, 2019. The first patient was enrolled on January 3, 2020, and the last was enrolled on October 25, 2021.Eligible patients were women aged 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0−1 and histologically confirmed treatment-naïve non-metastatic (stage IIA-IIIC) TNBC, defined as ER and PR negative or low expression by immunohistochemistry (PR or ER staining in <10% of tumor cells irrespective of intensity) and HER2 negative by immunohistochemistry (1, 1 +, or 2 +) or fluorescence in situ hybridization (<2.0) in core biopsies. Tumor staging was performed according to the eighth edition of the American Joint Committee on Cancer TNM staging system. Other key inclusion criteria were having measurable lesions of ≥2 cm or those of 1-2 cm with lymph node involvement on ultrasound or magnetic resonance imaging (MRI), no evidence of distant metastasis (bilateral mammography, breast ultrasound, chest X-ray, or computed tomography [CT] scan; liver ultrasound, CT or MRI scan; and bone scan), and having adequate organ function.Patients were excluded if they had inflammatory or metastatic breast cancer, other malignant diseases (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin), had previously received systematic treatment (including anti-PD-1/PD-L1 inhibitors) or radiotherapy, or if they had participated in another trial, or during pregnancy or lactation. Detailed information can be found in the study protocol (see Supplementary Note in the 