Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

Prior treatment

• Prior Anti-Cancer Treatments.
• Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment.
• Received palliative local treatments within 2 weeks before enrollment.
• Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment.
• Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment.
• Prior PD-1/PD-L1 Treatment.
• Previously received treatment with PD-1 inhibitors or PD-L1 inhibitors.
• Concurrent Participation in Other Clinical Studies.

Other illness

• History of Other Malignancies:
  • (1) Has a history of other malignant tumors within 5 years prior to enrollment or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and thyroid cancer.
  • (2) Active Autoimmune Diseases: Has active autoimmune diseases that required systemic treatment (such as corticosteroids) within 2 years before enrollment, or has autoimmune diseases that the investigator judges may recur or require planned treatment.

Other

• Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.

• Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures.
• Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form.
• Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR \< 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 "0\~1+"; or immunohistochemistry HER2 "2+" with no amplification on HER2 FISH gene testing).
• Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded \[FFPE\] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review.
• Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy.