Breast Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 77 |
Est. completion date | May 30, 2025 |
Est. primary completion date | May 10, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety of microwave ablation | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 | 10 days |
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