Breast Cancer
Conditions
Keywords
Ablation
Brief 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.
Interventions
PROCEDUREMicrowave Ablation
Preoperative US-guided microwave ablation of breast cancer
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation rate | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of microwave ablation | 10 days | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 |
Countries
China
Contacts
Primary ContactWenbin Zhou,, Professor
Outcome results
None listed