Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC (SCHBCC-N0105)

Fudan University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07290153

SCHBCC-N0105

Details and patient eligibility

About

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.

Full description

The goal of this prospective observational study is to understand how psychological status influences the therapeutic response and long-term outcomes of patients with triple-negative breast cancer (TNBC) receiving neoadjuvant immunotherapy. The study primarily focuses on the association between psychological status and pathological complete response (pCR) as well as event-free survival (EFS).

In this study, early-stage TNBC patients undergoing standard neoadjuvant immunotherapy will complete psychological assessments at baseline and multiple timepoints during treatment. Measurement include self-assessment questionnaires like GAD-7 and PHQ-9 and clinician-administered depression assessment scale like Hamilton Depression Rating Scale (HDRS). Blood and saliva samples will be collected to measure immune cell subsets, inflammatory cytokines, cortisol, and heart rate variability (HRV). Treatment response (pCR, ORR) and long-term outcomes (EFS) will be recorded and analyzed. By integrating psychological measures, circulating immune markers, and clinical efficacy endpoints, researchers aim to build a psychological-immune-response association model and identify psychophysiological biomarkers that may predict immunotherapy benefit.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

120 participants in 2 patient groups

Chemotherapy plus PD-1/PD-L1 inhibitor (Chemo-immunotherapy arm)

Description:

Patients in this arm will receive standard chemotherapy in combination with a PD-1/PD-L1 inhibitor as neoadjuvant therapy prior to definitive surgery. Concomitant treatments may be administered when clinically indicated.

ADC plus PD-1/PD-L1 inhibitor (ADC-immunotherapy arm)

Description:

Patients in this arm will receive an antibody-drug conjugate (ADC) in combination with a PD-1/PD-L1 inhibitor as neoadjuvant therapy prior to definitive surgery. Concomitant treatments may be administered when clinically indicated.