The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Female
• Interventions: Device: Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)

• Registration Number: NCT06635096
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Status Verified: 2024-10
• Study Start: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-03-07
• Study Completion: 2026-10-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Female，age 18-80 years.
2. Invasive carcinoma confirmed by core biopsy.
3. Newly diagnosed breast cancer patients, without neoadjuvant therapy.
4. Imaging findings showed an unifocal breast tumor with a maximum diameter of 2 cm, with no distant metastasis, no calcification, no skin or nipple adhesion, and no invasion of chest wall.
5. The functional level of major organs must meet the following requirements: blood routine: neutrophil (ANC)≥1.5×10^9/L; platelet count (PLT) ≥ (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90g/L; coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.

Exclusion Criteria

1. Tumor involving skin, ulceration, inflammatory breast cancer patients.
2. Tumor involving the superficial layer of the skin.
3. KPS score < 70, or ECOG score > 2
4. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
5. Heart, brain, lung, kidney and other vital organ failure.
6. Uncorrectable severe coagulopathy
7. Patient is pregnant or lactating
8. Poor glycemic control in diabetes
9. Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
10. Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
11. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
12. Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multimodal Thermal Therapy alone	Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)	Multimodal Thermal Therapy

Primary Outcome Measures

Name	Time	Method
Complete ablation rate	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Safety of Multimodal Tumor Thermal Therapy	In 1 year	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0.
Breast MRI confirmed complete ablation.	In 6 months	According to the mRECIST criteria, the complete ablation was confirmed by breast MRI in 6 months after multimodal thermal therapy.
Breast self evaluation	In 1 year	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.
Assessment of immune activating response	In 1 year	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.

Trial Locations

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China