Radiofrequency of Breast Cancers in Non Surgical Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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US-RF + endocrine therapy

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No