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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Breast Cancer Female NOS; General Anxiety Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Zhi-Ming Shao; Phone Number: +86-021-64175590; Email: zhimin_shao@yeah.net

Study Locations

• China
  • Please Select
    • Shanghai, Please Select, China, 20080
      • Recruiting
      • Fudan University Shangahi Cancer Center
      • Contact: Zhi-Ming Shao; Phone Number: +86-021-64175590; Email: zhimin_shao@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from women diagnosed with early-stage triple-negative breast cancer who are receiving neoadjuvant immunotherapy at Fudan University Shanghai Cancer Center (FUSCC). The study population consists of both outpatient and inpatient breast cancer patients treated at this tertiary cancer referral center, which serves a large and diverse region across Shanghai and surrounding regions. Eligible participants will be enrolled prior to initiation of neoadjuvant treatment and followed throughout the perioperative period.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chemotherapy plus PD-1/PD-L1 inhibitor (Chemo-immunotherapy arm); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Rate	Pathological complete response (pCR) is defined as the absence of residual invasive cancer in the breast and axillary lymph nodes (ypT0/Tis ypN0) after completion of neoadjuvant therapy. pCR will be assessed by investigators according to institutional pathology standards. The primary objective of this study is to evaluate the association between patients' psychological status and pCR.	At the time of definitive surgery
Event-Free Survival (EFS)	Event-free survival (EFS) is defined as the time from initiation of neoadjuvant immunotherapy until the date of one of the following events, whichever occurs first: disease recurrence, progression during neoadjuvant or adjuvant therapy, second primary malignancy, or death from any cause. Patients without an event at the end of follow-up will be censored at their last disease assessment. The study aims to investigate the relationship between baseline psychological status and long-term oncologic outcomes (EFS) in TNBC patients.	18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) to immunotherapy, as assessed by investigators according to RECIST v1.1 criteria. This outcome will be used to evaluate the association between patients' psychological status and immunotherapy response.	18 Months
Correlation Between Psychological Status-Related Blood Biomarkers and Treatment Response	Peripheral blood indicators that are found to be associated with psychological stress (e.g., systemic inflammation markers, cytokine signatures) will be further examined for their correlation with both pCR and ORR to explore potential psychoneuroimmune pathways mediating treatment response.	18 Months
Quality of Life and Emotional Trajectory During Treatment	Quality of life (QoL) and emotional changes over the course of treatment will be assessed longitudinally using validated instruments (e.g., SF-36, EORTC QLQ-C30). This outcome aims to evaluate the impact of psychological status on patients' treatment experience and well-being throughout the therapeutic course.	18 Months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Mood Disorders; Skin Diseases; Breast Diseases; Anxiety Disorders; Skin and Connective Tissue Diseases; Depressive Disorder; Breast Neoplasms; Generalized Anxiety Disorder
• Other Study ID Numbers: SCHBCC-N0105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No