Actively Recruiting
Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
Led by Fudan University · Updated on 2025-12-18
120
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Female patients
- Voluntarily agrees to participate and complete follow-up assessments
- Histologically confirmed invasive triple-negative breast cancer (ER < 1%, PR < 1%, HER-2 0-1+ or HER-2 2+ with negative gene amplification)
- Planned to receive neoadjuvant immunotherapy as routine care
You will not qualify if you...
- Presence of distant metastasis
- History of other cancers except treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or cancers with no evidence of disease for 5 or more years
- Participation in another clinical trial with investigational treatment within 30 days before neoadjuvant therapy
- Known immunodeficiency or HIV infection
- Severe cardiac, pulmonary, hepatic, or renal dysfunction
- Uncontrolled or active systemic infection
- Pregnancy or breastfeeding
- Severe psychological or cognitive impairment preventing completion of psychological assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shangahi Cancer Center
Shanghai, Please Select, China, 20080
Actively Recruiting
Research Team
Z
Zhi-Ming Shao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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