Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Chemotherapy plus PD-1/PD-L1 inhibitor (Chemo-immunotherapy arm)
Group B: ADC plus PD-1/PD-L1 inhibitor (ADC-immunotherapy arm)
Trial outcomes
Primary outcomes
1
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.
Time frame
At the time of definitive surgery2
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.
Time frame
18 MonthsSecondary outcomes
1
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.
Time frame
18 Months2
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.
Time frame
18 Months3
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.
Time frame
18 MonthsSponsors and contacts
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Source ClinicalTrials.gov