Radiofrequency of Breast Cancers in Non Surgical Patients (RF-SEIN)

September 10, 2025 updated by: Institut Bergonié

Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

To determine the efficacy and tolerance of ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy in elderly patients with breast cancer who decline or are not candidates for surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is increasing demand for minimally invasive treatments for small breast malignancies. This is due in part to increased availability of improved treatment approaches, with the introduction of neoadjuvant strategies, and for cosmetic reasons. Moreover, with the introduction of breast cancer screening programs, tumors are frequently diagnosed earlier and at a smaller size, enabling breast-conserving treatment with lumpectomy followed by whole-breast radiation therapy. For elderly patients, however, various physiologic alterations, comorbid diseases, and higher risk of complications are often perceived as contraindications to breast-conserving methods). In addition, elderly cancer patients generally receive fewer surgeries than younger patients. In this context, radiofrequency (RF) ablation is emerging as a minimally invasive nonsurgical technique for the treatment of small breast malignancies. Several pilot studies have published RF ablation tolerance and feasibility results for patients of all ages with small breast cancers and for small cohorts of elderly patients, but there is a lack of prospective data on long-term follow- up and long-term efficacy for elderly patients. In this prospective, single-arm study, we aimed to determine the efficacy and patient tolerance of ultrasonography (US)-guided percutaneous RF ablation with endocrine therapy for elderly patients with breast cancer who decline or are not candidates for surgery.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients more than 70 years old
  • Breast tumors with estrogen receptors
  • Non surgical patients
  • Life expectancy more than 6 months

Exclusion criteria:

  • Presence of a pace maker
  • Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle
  • Coagulation disorders
  • Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection
  • Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US-RF + endocrine therapy
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
Procedure: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Disease Recurrence One Year After the Intervention.
Time Frame: one year

The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy.

Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Disease Recurrence at 5 Years
Time Frame: 5 years after the intervention

The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy.

Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging).
5 years after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Fabienne VALENTIN, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 21, 2005

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2004-16
  • RF SEIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe