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CompletedNCT06636591Updated Jul 8, 2026

Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer

An interventional study of 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 Breast Cancer Female and HER2-negative Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer Female
  • HER2-negative Breast Cancer
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Triple-negative Breast Cancer with Non-immunomodulatory Subtype

    Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin

  • Experimental
    Hormone Receptor-positive (HR+) and HER2-negative (HER2-)

    Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin

Interventions

  • Combination productDevice: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin

    Drugs was given a few days after multimodal thermal therapy

  • Combination productDevice: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin

    Drugs was given a few days after multimodal thermal therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

    Time frame: up to 28 weeks

07

Study locations

1 site
  • Breast cancer institute of Fudan University Cancer Hospital
    Shanghai, Shanghai Municipality 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06636591
Lead sponsor
Fudan University
Responsible party
Zhimin Shao (Professor, Fudan University) — Principal investigator
First posted
Oct 10, 2024
Start date
Dec 23, 2024
Primary completion
Jan 7, 2026
Completion
Jun 30, 2026
Last update
Jul 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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