Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
NCT ID: NCT07290153
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2026-01-01
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chemotherapy plus PD-1/PD-L1 inhibitor (Chemo-immunotherapy arm)
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.
No interventions assigned to this group
ADC plus PD-1/PD-L1 inhibitor (ADC-immunotherapy arm)
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Locations
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Fudan University Shangahi Cancer Center
Shanghai, Please Select, China
Countries
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Central Contacts
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Facility Contacts
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Zhi-Ming Shao
Role: primary
Other Identifiers
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SCHBCC-N0105
Identifier Type: -
Identifier Source: org_study_id