RecruitingNCT07290153

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


Sponsor

Fudan University

Enrollment

120 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a patient's psychological state and immune system response interact during pre-surgery immunotherapy treatment for triple-negative breast cancer (TNBC), which is an aggressive type of breast cancer that lacks the three main hormone receptors. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with invasive triple-negative breast cancer (confirmed by biopsy) - You are planning to receive immunotherapy-based treatment before surgery as part of your standard care **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (distant metastasis) - You have a history of another cancer (with some exceptions for treated skin cancers) - You have conditions that make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Fudan University Shangahi Cancer Center

Shanghai, Please Select, China

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NCT07290153


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