QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

Prior treatment

• Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
• Administration of a vaccine within 30 days before the first dose of the study treatment;

Other illness

• History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
• Stage IV metastatic breast cancer;
• Subjects with severe systemic diseases;
• Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
• Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
• Subjects with known allergies to the study drug or any of its excipients;
• Any other condition deemed inappropriate for participation in the study by the investigator.
  • \-

Other

• Lactating women should discontinue breastfeeding during the study;

• Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
• Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
• Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
• Treatment-naïve subjects;
• Age ≥18 years, both genders eligible;
• ECOG performance status 0-1;
• Adequate bone marrow, cardiac, and organ function;
• Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
• Ability to comprehend and provide written informed consent.