Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female NOS, General Anxiety Disorder, Depressive Disorder. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Observational Study of Psychological State, Immunotherapy Response, and Multi-Omics Features in Triple-Negative Breast Cancer
Overview
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.
Detailed description
The goal of this prospective observational study is to understand how psychological status influences the therapeutic response and long-term outcomes of patients with triple-negative breast cancer (TNBC) receiving neoadjuvant immunotherapy. The study primarily focuses on the association between psychological status and pathological complete response (pCR) as well as event-free survival (EFS).
In this study, early-stage TNBC patients undergoing standard neoadjuvant immunotherapy will complete psychological assessments at baseline and multiple timepoints during treatment. Measurement include self-assessment questionnaires like GAD-7 and PHQ-9 and clinician-administered depression assessment scale like Hamilton Depression Rating Scale (HDRS). Blood and saliva samples will be collected to measure immune cell subsets, inflammatory cytokines, cortisol, and heart rate variability (HRV). Treatment response (pCR, ORR) and long-term outcomes (EFS) will be recorded and analyzed. By integrating psychological measures, circulating immune markers, and clinical efficacy endpoints, researchers aim to build a psychological-immune-response association model and identify psychophysiological biomarkers that may predict immunotherapy benefit.
Primary outcome measures
- Pathological Complete Response (pCR) Rate [Time frame: At the time of definitive surgery]
- Event-Free Survival (EFS) [Time frame: 18 Months]
Secondary outcome measures (3)
- Objective Response Rate (ORR) [Time frame: 18 Months]
- Correlation Between Psychological Status-Related Blood Biomarkers and Treatment Response [Time frame: 18 Months]
- Quality of Life and Emotional Trajectory During Treatment [Time frame: 18 Months]
Eligibility criteria
Inclusion Criteria：
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 criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shangahi Cancer Center — Shanghai
Identifiers
NCT: NCT07290153 · SCHBCC-N0105