Active — Not RecruitingNot Applicable

Excision Followed by Radiofrequency Ablation for Breast Cancer

United States104 participantsStarted 2010-06

Plain-language summary

The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.

Who can participate

Age range50 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is a female, ≥ 50 years of age * The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam) * The tumor is unicentric and unilateral * The tumor is not involving the skin * Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III * If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+) * Patient signs current written informed consent and HIPAA forms Exclusion Criteria: * Patient is under 50 years of age * Patient is male * Tumor \> 3 cm in diameter * Bilateral malignancy * Clinically positive lymph nodes * Tumor involving the skin * Pathology confirms invasive lobular carcinoma * Breast implants * Less than 2 years disease-free survival from previous breast cancer * Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

What they're measuring

Estimate the re-excision rate for close (<3mm) or positive margins

Timeframe: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)

Decrease local recurrence

Timeframe: Monitor throughout 5 year follow-up

Trial details

NCT IDNCT01153035

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06