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.
- EligibilityCriteria: 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 ) 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%.  Exclusion Criteria:  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. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult