Breast Cancer FemaleNCT06636591
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
A study testing Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin and Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin in people with Breast Cancer Female and HER2-negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
In this study, breast cancer (BC) patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping, which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy, to explore methods of immune induction for BC, enhance the efficacy of… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female, HER2-negative Breast Cancer
- What is being tested?
- Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin and Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Female，age 18-70 years.
- Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria;
- TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC);
- At least one measurable lesion according to RECIST 1.1 criteria;
- 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);
- LVEF ≥55%;
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- 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;
- Ability to understand and willingness to sign a written informed consent.
Who cannot join
- Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
- Patients with severe systemic infections or other serious diseases;
- Patients with known allergy or intolerance to the study drug or its excipients;
- Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
- Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
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- Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
- Endocrine system disorders;
- Patients who were judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Prospective, Open-label, Single-center, Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
In this study, breast cancer (BC) patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping, which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy, to explore methods of immune induction for BC, enhance the efficacy of immunotherapy, and accumulate data for subsequent stages of clinical study.
Read the detailed description
Local tumor destruction with non-surgical ablation (NSA, cryoablation or radiofrequency) induces inflammation and releases antigens that can activate tumor-specific immune responses.
Pre-clinically, we demonstrated that multimodal thermal therapy (MTT) as an integrated treatment modality of cryotherapy and radiofrequency heating, can effectively activate systemic and long-lasting antitumor immunity.
In this pilot study, patients with operable HER2-negative breast cancer were designed to receive a combination of MTT, immunotherapy and neoadjuvant chemotherapy. Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination, revealing the possibility for induced and synergistic anti-tumor immunity with this strategy.
- Conditions
- Breast Cancer Female, HER2-negative Breast Cancer
- Being tested
- Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin, Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: CarboplatinCombination product
Drugs was given a few days after multimodal thermal therapy
Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: GoserelinCombination product
Drugs was given a few days after multimodal thermal therapy
| Study group | Role | What they receive |
|---|---|---|
| Triple-negative Breast Cancer with Non-immunomodulatory Subtype | Experimental | Not described Receives: Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin |
| Hormone Receptor-positive (HR+) and HER2-negative (HER2-) | Experimental | Not described Receives: Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of immune activating response
- Proportion of subjects with immune response to combination therapy detected by biomarkers in peripheral blood samples
- Evaluate the infiltration of immune cells in tumor areas and adjacent tissues
Measured: up to 28 weeks
Secondary outcomes (1)
CTCAE scale (V4.0)
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0)
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start23 Dec 2024
- Primary completion7 Jan 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- NCT06636591
- Sponsor's protocol ID
- MTT-BC-002
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-center, Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06636591
- Acronym / sponsor ID
- MTT-BC-002
- Conditions
- Breast Cancer Female, HER2-negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Oct 2024 (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.
In this study, breast cancer (BC) patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping, which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy, to explore methods of immune induction for BC, enhance the efficacy of immunotherapy, and accumulate data for subsequent stages of clinical study.
Detailed description
Local tumor destruction with non-surgical ablation (NSA, cryoablation or radiofrequency) induces inflammation and releases antigens that can activate tumor-specific immune responses.
Pre-clinically, we demonstrated that multimodal thermal therapy (MTT) as an integrated treatment modality of cryotherapy and radiofrequency heating, can effectively activate systemic and long-lasting antitumor immunity.
In this pilot study, patients with operable HER2-negative breast cancer were designed to receive a combination of MTT, immunotherapy and neoadjuvant chemotherapy. Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination, revealing the possibility for induced and synergistic anti-tumor immunity with this strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple-negative Breast Cancer with Non-immunomodulatory Subtype | Experimental | Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin |
| Hormone Receptor-positive (HR+) and HER2-negative (HER2-) | Experimental | Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female，age 18-70 years.
- Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria;
- TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC);
- At least one measurable lesion according to RECIST 1.1 criteria;
- 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);
Key exclusion criteria (9 listed)
- Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
- Patients with severe systemic infections or other serious diseases;
- Patients with known allergy or intolerance to the study drug or its excipients;
- Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: CarboplatinDrugs was given a few days after multimodal thermal therapy | Combination product | Triple-negative Breast Cancer with Non-immunomodulatory Subtype |
| Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: GoserelinDrugs was given a few days after multimodal thermal therapy | Combination product | Hormone Receptor-positive (HR+) and HER2-negative (HER2-) |
Primary outcome
Assessment of immune activating response
Time frame: up to 28 weeks
* Proportion of subjects with immune response to combination therapy detected by biomarkers in peripheral blood samples * Evaluate the infiltration of immune cells in tumor areas and adjacent tissues
1 secondary outcome
CTCAE scale (V4.0)
Time frame: up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin and Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin in people with Breast Cancer Female and HER2-negative Breast Cancer, 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 9 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: finished, as of the sponsor's last update on 8 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of immune activating response (time frame: up to 28 weeks). 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 8 Jul 2026.