Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC

Prior treatment

• Participation in another clinical trial and receipt of an investigational drug or treatment within 30 days before initiation of neoadjuvant therapy;

Other illness

• Patients will be excluded if any of the following conditions apply:
• Known immunodeficiency or HIV infection;
• Severe cardiac, pulmonary, hepatic, or renal dysfunction;
• Uncontrolled infection or active systemic infection;
• Severe psychological or cognitive impairment that precludes completion of psychological assessments.

Age

• History of other malignancies, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or cancers with no evidence of disease for ≥ 5 years;

Other

• Presence of distant metastasis;
• Pregnancy or breastfeeding;

• Participants must meet all of the following criteria:
• Age ≥ 18 years;
• Female patients;
• Voluntarily agrees to participate in the study and signs the informed consent form, with good compliance and willingness to complete follow-up assessments;
• Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as ER \< 1%, PR \< 1%, and HER-2 0-1+ by IHC, or HER-2 2+ with negative FISH/CISH results (no gene amplification);
• Planned to receive neoadjuvant immunotherapy-based treatment as part of routine clinical care.