Phase 2
Completed N=107
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Cancer of the Breast
Source: ClinicalTrials.gov NCT00571987 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Number of Patients Requiring 2nd Surgery for Close or Positive Margins — 22 participants
Summary
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Requiring 2nd Surgery for Close or Positive Margins |
22 | — |
| SECONDARY Recurrence of Breast Cancer at Prior Site of Disease |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Female, 18-100 years old
- Not pregnant or breastfeeding
- Pre-study radiologic documentation of:
- size ≤ 5 cm
- unicentric, unilateral
- suspicious mass or calcification
- BIRADS classification ≥ IV
- location of abnormality > 1 cm from skin
- Ductal or Infiltrating Ductal Carcinoma
- Grade I-III on final pathology
- Good general health
- Zubrod Performance Status of 0, 1, or 2
- No previous chemotherapy
- No palpable axillary or supraclavicular lymph nodes
- If prior non-breast malignancy, must have > 5 year disease-free survival
Exclusion Criteria
- Patient 100 y/o
- Pregnant or breastfeeding
- Male
- Breast implants
- Multicentric disease or bilateral disease
- Lesions > 5 cm in diameter
- Lesions < 1.0 cm from the skin
- Previous prior radiation to the breast
- Need for mastectomy
- Diffuse microcalcifications (as determined by the Investigator)
Data sourced from ClinicalTrials.gov (NCT00571987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.