A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
Female patients aged between 18 and 70 years old.
Pathologically confirmed as invasive breast cancer, with immunohistochemical staining indicating HER2 negativity, as specifically referenced in the guidelines of the American Society of Clinical
Oncology/College of American Pathologists (ASCO/CAP).
Clinical stage II-III, patients who are planned to undergo neoadjuvant treatment to downstage for surgery or who wish to have breast-conserving surgery after neoadjuvant treatment.
Prior receipt of chest radiotherapy, chemotherapy, or immunotherapy.
History of other malignancies, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid cancer.
Patients with active fibroconnective tissue diseases, risk of active autoimmune diseases, or a history of autoimmune diseases that may involve the central nervous system, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, and autoimmune neuropathies (e.g., Guillain-Barré syndrome). The following exceptions apply: Type I diabetes mellitus, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic therapy, and autoimmune diseases caused by B cells or anti-self-antigen antibodies.
Pulmonary disease defined as ≥ Grade 3 according to the NCI-CTCAE v5.0; history of interstitial lung disease (ILD) requiring corticosteroid treatment (including pulmonary fibrosis or radiation pneumonitis), or current ILD or ≥ Grade 2 radiation pneumonitis.