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Completed

NCT Number: NCT00210223

Radiofrequency of Breast Cancers 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.

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Key information

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

Acronym: RF-SEIN

Important dates

Study start
2004
Primary completion
2010
Study completion
2011
First posted
Sep 21, 2005
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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