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
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.
• The breast tumor is suitable for SBRT (stereotactic body radiotherapy) (tumor distance from the skin \> 5 mm, without invasion of the ribs or intercostal muscles).
• No distant metastasis detected by clinical examination combined with imaging studies (including but not limited to liver ultrasound, chest CT, bone scan, PET-CT).
• Adequate organ function (hemoglobin ≥ 100 g/L, white blood cells ≥ 3×10⁹/L, neutrophils ≥ 1.5×10⁹/L, platelets ≥ 80×10⁹/L; creatinine ≤ 132 μmol/L; alanine aminotransferase/aspartate aminotransferase ≤ 2.5×upper normal limit \[UNL\]).
• Capable of undergoing breast magnetic resonance imaging (MRI) scans. Eligible for follow-up conditions.
• The subject is able to sign the informed consent form to participate in the study.
⁃ Women of childbearing age are not pregnant, not breastfeeding, and are using effective contraception.