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

NCT06288620 | Recruiting

• 1 other identifier: MA-EBC-II-024
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of microwave ablation

  10 days

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

Preoperative US-guided microwave ablation of breast cancer

Procedure: Microwave Ablation

Interventions

Microwave Ablation PROCEDURE

Preoperative US-guided microwave ablation of breast cancer

Microwave Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients aged 18-70 years;
• patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
• 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;
• 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;
• the tumor without adhesion to chest wall, nipple or skin;
• patients without distant metastasis;
• Karnofsky performance status greater than 70%.

You may not qualify if:

• multicentric or multifocal breast tumor;
• the tumor located on nipple and areola area;
• 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);
• extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;
• invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;
• patients who were pregnant or breastfeeding;
• patients with evidence of coagulopathy, chronic liver diseases or renal failure;
• patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc;
• patients with substance abuse, or mental or psychological disorders that may interfere with study compliance;
• any condition that is unstable or likely to compromise the patient's safety and compliance;
• patients enrolled in other clinical trials;
• diseases or symptoms that other investigators consider unsuitable for participation.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wenbin Zhou,, Professor

CONTACT

025-68308162; zhouwenbin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: February 25, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 30, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)