Cancer of the Breast
Conditions
Keywords
Breast cancer, Lumpectomy, Radiofrequency Ablation, Negative margins, Breast Conserving Surgery
Brief 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.
Detailed description
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \ 40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.
Interventions
DEVICEAngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Sponsors
Angiodynamics, Inc.
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \< 18 y/o or \> 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring 2nd Surgery for Close or Positive Margins | Margins assessed at Final Pathology, approximately 1 week post-RF surgery | A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm. |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of Breast Cancer at Prior Site of Disease | Until study end (2 years) |
Countries
United States
Participant flow
Recruitment details
The first subject was consented to the study in September 2004. The final subject was consented in March 2010. A total of 107 subjects were consented.
Pre-assignment details
As part of this non-blinded and non-randomized study all participants receive ablation.
Participants by arm
| Arm | Count |
|---|---|
| RFA Treatment AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed. | 107 |
| Total | 107 |
Baseline characteristics
| Characteristic | RFA Treatment |
|---|---|
| Age, Continuous | 65.02 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 107 |
| serious Total, serious adverse events | 0 / 107 |
Outcome results
Primary
Number of Patients Requiring 2nd Surgery for Close or Positive Margins
A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm.
Time frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Margin Status | Number of Patients Requiring 2nd Surgery for Close or Positive Margins | 22 participants |
Secondary
Recurrence of Breast Cancer at Prior Site of Disease
Time frame: Until study end (2 years)
Population: During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Margin Status | Recurrence of Breast Cancer at Prior Site of Disease | 2 participants |