Breast CancerRF-SEINNCT00210223
Radiofrequency of Breast Cancers in Non Surgical Patients
A study testing ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patients more than 70 years old
- Breast tumors with estrogen receptors
- Non surgical patients
- Life expectancy more than 6 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
About this study
Official title: Radiofrequency of Breast Cancers : Pilot Study 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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
- Keywords
- Radiofrequency, Percutaneous technique, breast cancer, tolerance
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapyProcedure or surgery
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| US-RF + endocrine therapy | Experimental | ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy Receives: Procedure: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Secondary outcomes (1)
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).
Measured: 5 years after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne VALENTIN, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210223
- Sponsor's protocol ID
- IB2004-16
- Acronym
- RF-SEIN
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2005
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
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.
PubMed 22692040
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients
- ClinicalTrials.gov ID
- NCT00210223
- Acronym / sponsor ID
- RF-SEIN / IB2004-16
- Conditions
- Breast Cancer
- Keywords
- Radiofrequency, Percutaneous technique, breast cancer, tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| US-RF + endocrine therapy | Experimental | Procedure: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapyultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients more than 70 years old
- Breast tumors with estrogen receptors
- Non surgical patients
- Life expectancy more than 6 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapyultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy | Procedure or surgery | US-RF + endocrine therapy |
Primary outcome
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).
1 secondary outcome
Number of Participants With Disease Recurrence at 5 Years
Time frame: 5 years after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22692040Palussiere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne VALENTIN, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Disease Recurrence One Year After the Intervention. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.