Heating up tumors: could thermal therapy boost immune attack on breast cancer?
NCT ID NCT06636591
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This pilot study tests whether adding a special heat therapy (multimodal thermal therapy) to standard chemotherapy and immunotherapy can help the immune system better recognize and attack HER2-negative breast cancer. The study enrolls women aged 18–70 with certain subtypes of breast cancer who have not yet had surgery. Researchers will measure immune cell activity in blood and tumor tissue to see if the combination triggers a stronger immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Camrelizumab, Nab paclitaxel, Carboplatin, Goserelin, Multimodal Tumor Thermal Therapy System
- What this could lead to
- If successful, this approach could improve immune activation against breast cancer, potentially leading to better outcomes before surgery.
- What could go wrong
- This is a very small pilot study (14 people) with no control group, so results may not be generalizable. The combination therapy may cause side effects without clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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14 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Jun 2026
- 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.
- 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: 1. Female,age 18-70 years. 2. Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria; 3. TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC); 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 6. LVEF ≥55%; 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 8. Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; 9. Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: 1. Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2. Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II); 3. Patients with severe systemic infections or other serious diseases; 4. Patients with known allergy or intolerance to the study drug or its excipients; 5. Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study; 7. Participated in other trial studies within 30 days before the administration of the first dose of the study drug; 8. Endocrine system disorders; 9. Patients who were judged by the investigator to be unsuitable for this study.
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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.
Contacts and locations
Locations
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Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
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