Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective, Open-label, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288620
• Other study ID #: MA-EBC-II-024
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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