Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
Prospective Observational Study of Psychological State, Immunotherapy Response, and Multi-Omics Features in Triple-Negative Breast Cancer
Fudan University
120 participants
Jan 1, 2026
OBSERVATIONAL
Conditions
Summary
This study aims to evaluate whether psychological status affects the response to neoadjuvant immunotherapy in triple-negative breast cancer (TNBC) and how it relates to immune changes during treatment. Participants will receive standard therapy, undergo psychological assessments, and provide blood and saliva samples for biomarker testing. By linking psychological status with immune profiles and treatment outcomes, the study seeks to clarify how mental state may influence immunotherapy effectiveness.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria9
- Patients will be excluded if any of the following conditions apply:
- Presence of distant metastasis;
- 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;
- Participation in another clinical trial and receipt of an investigational drug or treatment within 30 days before initiation of neoadjuvant therapy;
- Known immunodeficiency or HIV infection;
- Severe cardiac, pulmonary, hepatic, or renal dysfunction;
- Uncontrolled infection or active systemic infection;
- Pregnancy or breastfeeding;
- Severe psychological or cognitive impairment that precludes completion of psychological assessments.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07290153