Mind over medicine: can your emotions boost cancer therapy?
NCT ID NCT07290153
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a person's mental state—like anxiety or depression—can influence how well immunotherapy works for triple-negative breast cancer. About 120 women will receive standard treatment, complete psychological surveys, and give blood and saliva samples. Researchers hope to find links between mental health, immune changes, and treatment success.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shangahi Cancer Center
RECRUITINGShanghai, Please Select, 20080, China
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