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

NCT ID: NCT06288620

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Ablation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Microwave Ablation
Description: Preoperative US-guided microwave ablation of breast cancer
Arm group label: Microwave Ablation

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: the First Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Wenbin Zhou, Professor

Start date: February 25, 2024

Completion date: May 30, 2025

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06288620

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