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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06288620
Other study ID # MA-EBC-II-024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2024
Est. completion date May 30, 2025

Study information

Verified date February 2024
Source The First Affiliated Hospital with Nanjing Medical University
Contact Wenbin Zhou,, Professor
Phone 025-68308162
Email zhouwenbin@njmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.


Recruitment information / eligibility

Status Recruiting
Enrollment 77
Est. completion date May 30, 2025
Est. primary completion date May 10, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. female patients aged 18-70 years; 2. patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy; 3. the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm; 4. the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score =4) evaluated by breast US, X-ray and MRI; 5. the tumor without adhesion to chest wall, nipple or skin; 6. patients without distant metastasis; 7. Karnofsky performance status greater than 70%. Exclusion Criteria: 1. multicentric or multifocal breast tumor; 2. the tumor located on nipple and areola area; 3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement > 2.5 cm on MRI); 4. extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology; 5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis; 6. patients who were pregnant or breastfeeding; 7. patients with evidence of coagulopathy, chronic liver diseases or renal failure; 8. patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc; 9. patients with substance abuse, or mental or psychological disorders that may interfere with study compliance; 10. any condition that is unstable or likely to compromise the patient's safety and compliance; 11. patients enrolled in other clinical trials; 12. diseases or symptoms that other investigators consider unsuitable for participation.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Microwave Ablation
Preoperative US-guided microwave ablation of breast cancer

Locations

Country Name City State
China the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete ablation rate The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining. 1 day
Secondary Safety of microwave ablation Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 10 days
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