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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhi-Ming Shao
• Email: zhimin_shao@yeah.net
• Phone: +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.