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

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.

ClinicalTrials.gov IDNCT07290153
PhaseNot Applicable
Enrollment120
SponsorFudan University
Age18 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Breast Cancer Female NOS, General Anxiety Disorder, Depressive Disorder

About this study

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.

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.