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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Microwave Ablation

• Study Type: Interventional
• Enrollment (Estimated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbin Zhou,, Professor; Phone Number: 025-68308162; Email: zhouwenbin@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Wenbin Zhou, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave Ablation; Preoperative US-guided microwave ablation of breast cancer	Procedure: Microwave Ablation; Preoperative US-guided microwave ablation of breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of microwave ablation	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0	10 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ablation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MA-EBC-II-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available from the corresponding author upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No