Microwave ablation for 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

This study is testing if microwave ablation can safely and effectively treat early-stage breast cancer in women with small tumors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06288620 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of microwave ablation (MWA) therapy as a minimally invasive treatment for early-stage unifocal invasive breast cancer. The study focuses on female patients aged 18-70 with newly diagnosed tumors smaller than 2 cm, confirmed through imaging techniques. It aims to determine the optimal indications for MWA and explore its immune-activating effects. The trial is conducted as a prospective, open-label, single-arm phase II study.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-70 with newly diagnosed unifocal invasive breast cancer tumors smaller than 2 cm.

Not a fit: Patients with multicentric or multifocal breast tumors or those with tumors located on the nipple and areola area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with early-stage breast cancer, potentially improving recovery times and outcomes.

How similar studies have performed: While microwave ablation has been explored in other contexts, this specific application for early-stage breast cancer is relatively novel and has not been extensively tested.

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.

Where this trial is running

Nanjing, Jiangsu

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wenbin Zhou,, Professor

Conditions Breast Cancer; Ablation