Clinical trial · Interventional
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave Ablation
- description
- Preoperative US-guided microwave ablation of breast cancer
- interventionNames
- Procedure: Microwave Ablation
Primary outcomes (1)
- measure
- Complete ablation rate
- timeFrame
- 1 day
- description
- 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 outcomes (1)
- measure
- Safety of microwave ablation
- timeFrame
- 10 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
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