Radiofrequency of Breast Cancers in Non Surgical Patients

NCT00210223 | Completed Results

• 1 other identifier: IB2004-16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Radiofrequency; Percutaneous technique; breast cancer; tolerance

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Disease Recurrence One Year 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).

  one year

Secondary Outcomes (1)

• Number of Participants With Disease Recurrence at 5 Years

  5 years after the intervention

Study Arms (1)

US-RF + endocrine therapy

EXPERIMENTAL

ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy

Procedure: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy

Interventions

ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy PROCEDURE

ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy

US-RF + endocrine therapy

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Location

Related Publications (1)

• Palussiere J, Henriques C, Mauriac L, Asad-Syed M, Valentin F, Brouste V, Mathoulin-Pelissier S, Tunon de Lara C, Debled M. Radiofrequency ablation as a substitute for surgery in elderly patients with nonresected breast cancer: pilot study with long-term outcomes. Radiology. 2012 Aug;264(2):597-605. doi: 10.1148/radiol.12111303. Epub 2012 Jun 12.

  PMID: 22692040 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Simone Mathoulin-Pélissier
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• Fabienne VALENTIN, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)