How mental health relates to immunotherapy response in triple-negative breast cancer

Prospective Observational Study of Psychological State, Immunotherapy Response, and Multi-Omics Features in Triple-Negative Breast Cancer

This project tries to see if a patient's mental health affects how well pre-surgery immunotherapy works for people with early triple-negative breast cancer.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Please Select)
• Trial ID: NCT07290153 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study of people with early-stage triple-negative breast cancer receiving standard neoadjuvant immunotherapy. Participants complete standardized psychological questionnaires (for example GAD-7, PHQ-9, and HDRS) at baseline and during treatment while providing blood and saliva samples. Laboratories will measure immune cell subsets, inflammatory cytokines, cortisol levels, and heart-rate variability alongside clinical endpoints such as pathological complete response and event-free survival. Data will be integrated to explore links between psychological state, circulating immune markers, and treatment outcomes.

Who should consider this trial

Good fit: Adult female patients with histologically confirmed early-stage triple-negative breast cancer who are planned for neoadjuvant immunotherapy and willing to complete questionnaires and provide blood and saliva samples are ideal candidates.

Not a fit: Patients with distant metastases, active other malignancies, those not receiving neoadjuvant immunotherapy, or those unwilling to complete serial assessments or provide samples are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, the work could identify psychological or blood-based markers that predict who is more likely to benefit from neoadjuvant immunotherapy and suggest targets for supportive mental-health interventions to improve outcomes.

How similar studies have performed: Previous research has linked psychological state to immune changes and cancer outcomes, but applying psychophysiological and multi-omics markers to predict neoadjuvant immunotherapy response in TNBC remains largely novel and unproven.

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.

Where this trial is running

Shanghai, Please Select

• Fudan University Shangahi Cancer Center — Shanghai, Please Select, China (Recruiting)

Study contacts

• Study coordinator: Zhi-Ming Shao

Conditions Breast Cancer Female NOS; General Anxiety Disorder; Depressive Disorder; Breast Cancer