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

Recruitingn/aAges 18 Years - 70 YearsFemaleFudan University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Participants must meet all of the following criteria: 1. Age ≥ 18 years; 2. Female patients; 3. Voluntarily agrees to participate in the study and signs the informed consent form, with good compliance and willingness to complete follow-up assessments; 4. 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); 5. Planned to receive neoadjuvant immunotherapy-based treatment as part of routine clinical care. Exclusion Criteria Patients will be excluded if any of the following conditions apply: 1. Presence of distant metastasis; 2. 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; 3. Participation in another clinical trial and receipt of an investigational drug or treatment within 30 days before initiation of neoadjuvant therapy; 4. Known immunodeficiency or HIV infection; 5. Severe cardiac, pulmonary, hepatic, or renal dysfunction; 6. Uncontrolled infection or active systemic infection; 7. Pregnancy or breastfeeding; 8. Severe psychological or cognitive impairment that precludes completion of psychological assessments.
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What it tests

  • Not listed
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Where

1 site
Fudan University Shangahi Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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