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

NCT ID: NCT06288620

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2025-05-30

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave Ablation

Preoperative US-guided microwave ablation of breast cancer

Group Type: EXPERIMENTAL

Microwave Ablation

Intervention Type: PROCEDURE

Preoperative US-guided microwave ablation of breast cancer

Interventions

Microwave Ablation

Preoperative US-guided microwave ablation of breast cancer

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenbin Zhou,, Professor

Role: CONTACT

zhouwenbin@njmu.edu.cn

025-68308162

Facility Contacts

Wenbin Zhou, Professor

Role: primary

Other Identifiers

MA-EBC-II-024

Identifier Type: -

Identifier Source: org_study_id