Breast Cancer Female NOSSCHBCC-N0105NCT07290153
Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
An observational study of Breast Cancer Female NOS and General Anxiety Disorder, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female NOS, General Anxiety Disorder, Depressive Disorder
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jun 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- Uncontrolled infection or active systemic infection;
- Pregnancy or breastfeeding;
- Severe psychological or cognitive impairment that precludes completion of psychological assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shangahi Cancer Center
Shanghai, Please Select, 20080
Zhi-Ming Shao, +86-021-64175590, zhimin_shao@yeah.net
About this study
Official title: 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.
Read the 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.
- Keywords
- Breast Cancer
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 Months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Female NOSStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290153
- Sponsor's protocol ID
- SCHBCC-N0105
- Acronym
- SCHBCC-N0105
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Psychological State, Immunotherapy Response, and Multi-Omics Features in Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07290153
- Acronym / sponsor ID
- SCHBCC-N0105 / SCHBCC-N0105
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of definitive surgery
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.
Event-Free Survival (EFS)
Time frame: 18 Months
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 18 Months
Correlation Between Psychological Status-Related Blood Biomarkers and Treatment Response
Time frame: 18 Months
Quality of Life and Emotional Trajectory During Treatment
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female NOS and General Anxiety Disorder, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Ming Shao (+86-021-64175590, zhimin_shao@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of definitive surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.