Phase 2 N=107 Treatment

Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

Cancer of the Breast

Bottom Line

View on ClinicalTrials.gov: NCT00571987 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Number of Patients Requiring 2nd Surgery for Close or Positive Margins — 22 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Arkansas
Primary completion: Jun 2013

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.