Excision Followed by Radiofrequency Ablation for Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Device: Radiofrequency Ablation

• Registration Number: NCT01153035
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery followed by RFA	Radiofrequency Ablation	-

Primary Outcome Measures

Name	Time	Method
Estimate the re-excision rate for close (<3mm) or positive margins	Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)	How many patients must go back for re-excision of margins
Decrease local recurrence	Monitor throughout 5 year follow-up	The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.

Trial Locations

Locations (6)

Sharp Oncology (Comprehensive Breast Care of San Diego); 🇺🇸 San Diego, California, United States

Comprehensive Breast Care of Denver; 🇺🇸 Denver, Colorado, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

The University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

Columbia; 🇺🇸 New York, New York, United States