Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov