Excision Followed by Radiofrequency Ablation for Breast Cancer (NCT01153035) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Excision Followed by Radiofrequency Ablation for Breast Cancer
United States104 participantsStarted 2010-06
Plain-language summary
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.
Who can participate
Age range
50 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is a female, ≥ 50 years of age
* The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
* The tumor is unicentric and unilateral
* The tumor is not involving the skin
* Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
* If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
* Patient signs current written informed consent and HIPAA forms
Exclusion Criteria:
* Patient is under 50 years of age
* Patient is male
* Tumor \> 3 cm in diameter
* Bilateral malignancy
* Clinically positive lymph nodes
* Tumor involving the skin
* Pathology confirms invasive lobular carcinoma
* Breast implants
* Less than 2 years disease-free survival from previous breast cancer
* Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimate the re-excision rate for close (<3mm) or positive margins
Timeframe: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)