Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC

NCT07290153 | Recruiting

• 1 other identifier: SCHBCC-N0105
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female NOS; General Anxiety Disorder; Depressive Disorder

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Objective Response Rate (ORR)

  18 Months

• Correlation Between Psychological Status-Related Blood Biomarkers and Treatment Response

  18 Months

• Quality of Life and Emotional Trajectory During Treatment

  18 Months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants must meet all of the following criteria:
• Age ≥ 18 years;
• Female patients;
• Voluntarily agrees to participate in the study and signs the informed consent form, with good compliance and willingness to complete follow-up assessments;
• 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);
• Planned to receive neoadjuvant immunotherapy-based treatment as part of routine clinical care.

You may not qualify if:

• Patients will be excluded if any of the following conditions apply:
• Presence of distant metastasis;
• 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;
• Participation in another clinical trial and receipt of an investigational drug or treatment within 30 days before initiation of neoadjuvant therapy;
• Known immunodeficiency or HIV infection;
• Severe cardiac, pulmonary, hepatic, or renal dysfunction;
• Uncontrolled infection or active systemic infection;
• Pregnancy or breastfeeding;
• Severe psychological or cognitive impairment that precludes completion of psychological assessments.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shangahi Cancer Center

Shanghai, Please Select, 20080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This study will collect serial biospecimens and imaging data during neoadjuvant immunotherapy. Peripheral blood samples will be obtained for cytokine and immune profiling. Saliva samples will be collected for cortisol assessment. Surgical tumor specimens will be obtained at the time of definitive surgery. Radiological imaging at each treatment evaluation timepoint will also be collected. These materials will be used to analyze the association between psychological status, immune activation, and treatment efficacy.

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depressive Disorder; Breast Neoplasms

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Mood Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhi-Ming Shao

CONTACT

+86-021-64175590; zhimin_shao@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)