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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-RF + endocrine therapy | Experimental | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy | Procedure | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Recurrence at 5 Years | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne VALENTIN, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22692040 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | US-RF + Endocrine Therapy | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | US-RF + Endocrine Therapy | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | one year |
|
5 years
Adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | US-RF + Endocrine Therapy | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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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
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Disease Recurrence at 5 Years | 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). | Posted | Count of Participants | Participants | 5 years after the intervention |
|
|
|
| 4 |
| 21 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D055585 |
| Physical Phenomena |