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Trial Title:
The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer
NCT ID:
NCT06635096
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)
Description:
These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal
Therapy System.
Arm group label:
Multimodal Thermal Therapy alone
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Zhimin Shao, M.D
Phone:
86-21-64175590
Email:
zhimingshao@yahoo.com
Start date:
October 8, 2024
Completion date:
October 7, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635096
