NCT07290153 Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
| NCT ID | NCT07290153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Breast Cancer Female NOS |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-01-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07290153 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer Female NOS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07290153 currently recruiting?
Yes, NCT07290153 is actively recruiting participants. Contact the research team at zhimin_shao@yeah.net for enrollment information.
Where is the NCT07290153 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07290153 clinical trial?
NCT07290153 is sponsored by Fudan University. The trial plans to enroll 120 participants.
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