This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.
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.
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.
Shuangyue Liu
Lead sponsor
West China Hospital
Sponsor institution