Clinical trial · Interventional
Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ
A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer
NCT00388115CI-TRIAL-00003303completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RFA prior to surgery
- interventionNames
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Procedure: radiofrequency ablation
Primary outcomes (1)
- measure
- Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy
- timeFrame
- At completion of study
Secondary outcomes (3)
- measure
- Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy
- timeFrame
- At completion of study
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females of ages ≥18 years. * Core biopsy proven invasive breast cancer OR * Core biopsy proven low or intermediate grade DCIS. * Tumor less than or equal to 2.0 cm in diameter. * No prior surgical treatment for breast cancer within 30 days. * Life expectancy of \> 10 years, not including the diagnosis of cancer. * ECOG performance status of 0-2. * Informed consent given. * Multifocal invasive breast cancer patients are eligible. All tumors that are palpable or visualized by USS can be treated. Exclusion Criteria: * Male subjects. * Ages \< 18 years. * Breast tumor \> 2.0 cm in diameter. * Evidence of distant metastatic disease. * Evidence of diffuse calcification suggestive of extensive or multifocal DCIS. * High grade DCIS or presence of comedo-necrosis because these lesions can be associated with invasive breast cancer, which would go undetected if the lesion is entirely destroyed by the RF ablation.
References
Publications (0)
Data not yet available
No reference posted for this study.