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

Institut Bergonié

Status: Completed

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00210223

IB2004-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

US-RF + endocrine therapy

Experimental group

Description:

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

Treatment:

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