Last updated: February 25, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Breast Cancer
Cancer
Treatment
Microwave Ablation
Clinical Study ID
NCT06288620
MA-EBC-II-024
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 ) wereperformed at the same time, and the difference of the largest diameter between breastUS and MRI was less than 0.5 cm;
- the single tumor without other suspicious lesions (BI-RADS (the Breast ImagingRecording 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%.
Exclusion
Exclusion Criteria:
- multicentric or multifocal breast tumor;
- the tumor located on nipple and areola area;
- signs of extensive intraductal carcinoma on imaging examination (diffuse malignantcalcification on breast X-ray or segmental distribution, non-mass enhancement, ductalor 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 sclerosingadenosis;
- 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, orlocal radiation therapy, etc;
- patients with substance abuse, or mental or psychological disorders that may interferewith study compliance;
- any condition that is unstable or likely to compromise the patient's safety andcompliance;
- patients enrolled in other clinical trials;
- diseases or symptoms that other investigators consider unsuitable for participation.
Study Design
Total Participants: 77
Treatment Group(s): 1
Primary Treatment: Microwave Ablation
Phase:
Study Start date:
February 25, 2024
Estimated Completion Date:
May 30, 2025
Connect with a study center
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
ChinaActive - Recruiting
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