Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female NOS | — | UNRESOLVED | — |
| Depressive Disorder | — | UNRESOLVED | — |
| General Anxiety Disorder | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy plus PD-1/PD-L1 inhibitor (Chemo-immunotherapy arm)
- description
- Patients in this arm will receive standard chemotherapy in combination with a PD-1/PD-L1 inhibitor as neoadjuvant therapy prior to definitive surgery. Concomitant treatments may be administered when clinically indicated.
- label
- ADC plus PD-1/PD-L1 inhibitor (ADC-immunotherapy arm)
- description
- Patients in this arm will receive an antibody-drug conjugate (ADC) in combination with a PD-1/PD-L1 inhibitor as neoadjuvant therapy prior to definitive surgery. Concomitant treatments may be administered when clinically indicated.
Primary outcomes (2)
- measure
- Pathological Complete Response (pCR) Rate
- timeFrame
- At the time of definitive surgery
- description
- Pathological complete response (pCR) is defined as the absence of residual invasive cancer in the breast and axillary lymph nodes (ypT0/Tis ypN0) after completion of neoadjuvant therapy. pCR will be assessed by investigators according to institutional pathology standards. The primary objective of this study is to evaluate the association between patients' psychological status and pCR.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available