Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study aimed to evaluate the efficacy and safety of MTT in the treatment of early-stage invasive breast cancer, and to explore the ablation-induced immune activating response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal Therapy System.
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Complete ablation rate
The complete ablation rate was confirmed by core needle biopsy 3 months after multimodal thermal therapy. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
Time frame: 3 months
Safety of Multimodal Tumor Thermal Therapy
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0.
Time frame: In 1 year
Breast MRI confirmed complete ablation.
According to the mRECIST criteria, the complete ablation was confirmed by breast MRI in 6 months after multimodal thermal therapy.
Time frame: In 6 months
Breast self evaluation
Breast self evaluation for patients will be assessed by Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores.The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Time frame: In 1 year
Assessment of immune activating response
Immune indicator analysis will be conducted to evaluate the immune status and response of participants to the intervention. This will include the assessment of various immune cell populations and markers, such as: * CD4+ and CD8+ T lymphocyte counts and ratios. * B cell counts and subsets. * Dendritic cell (DC) counts and functionality. * Monocyte counts and subsets.
Time frame: In 1 year
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