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

NCT06635096 | Not Yet Recruiting

• 1 other identifier: MTT-BC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• Safety of Multimodal Tumor Thermal Therapy

  In 1 year

• Breast MRI confirmed complete ablation.

  In 6 months

• Breast self evaluation

  In 1 year

• Assessment of immune activating response

  In 1 year

Study Arms (1)

Multimodal Thermal Therapy alone

EXPERIMENTAL

Multimodal Thermal Therapy

Device: Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)

Interventions

Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.) DEVICE

These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal Therapy System.

Multimodal Thermal Therapy alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female，age 18-80 years.
• Invasive carcinoma confirmed by core biopsy.
• Newly diagnosed breast cancer patients, without neoadjuvant therapy.
• 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.
• 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.

You may not qualify if:

• Tumor involving skin, ulceration, inflammatory breast cancer patients.
• Tumor involving the superficial layer of the skin.
• KPS score \< 70, or ECOG score \> 2
• Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
• Heart, brain, lung, kidney and other vital organ failure.
• Uncorrectable severe coagulopathy
• Patient is pregnant or lactating
• Poor glycemic control in diabetes
• Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
• Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
• 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).
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Central Study Contacts

Zhimin Shao, M.D

CONTACT

86-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 10, 2024
• Study Start: October 8, 2024
• Primary Completion: March 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (1)