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Radiofrequency Ablation for Breast Cancer (ABLATE Trial)

N/A
Waitlist Available
Led By Daniela Ochoa, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a female, ≥ 50 years of age
The tumor is unicentric and unilateral
Must not have
Pathology confirms invasive lobular carcinoma
Patient is under 50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitor throughout 5 year follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether using radiofrequency ablation to extend the "final" negative margin on breast cancer lumpectomy sites can decrease the rates of re-operation.

Who is the study for?
This trial is for women over 50 with breast cancer where the tumor is ≤ 3 cm, unicentric, unilateral, and not involving the skin. It's suitable if the cancer is ductal in situ or infiltrating ductal carcinoma that's hormone receptor positive. Women can't join if they're under 50, have clinically positive lymph nodes, invasive lobular carcinoma, bilateral malignancy or had recent chemotherapy.
What is being tested?
The study tests radiofrequency ablation (RFA) right after lumpectomy surgery to see if it helps extend tumor-free margins and reduce the need for more surgeries. RFA uses heat from radio waves to kill any remaining cancer cells around where the lump was removed.
What are the potential side effects?
Potential side effects of RFA may include discomfort at the treatment site, risk of burns on nearby tissue due to heat exposure during the procedure, infection risks at incision sites and possible impact on surrounding healthy breast tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 50 or older.
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My tumor is located in one area and on one side of my body.
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My breast cancer is hormone receptor positive.
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My tumor is 3 cm or smaller.
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My tumor does not affect the skin.
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My breast cancer is confirmed as DCIS or IDC, grade I-III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is invasive lobular carcinoma.
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I am younger than 50 years old.
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My tumor is larger than 3 cm.
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I have cancer in both sides of a paired organ.
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My cancer affects the skin.
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My lymph nodes are enlarged or abnormal.
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I was diagnosed with breast cancer less than 2 years ago and it has not returned.
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I have had chemotherapy for breast cancer within the last two years.
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I am male.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitor throughout 5 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitor throughout 5 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decrease local recurrence
Estimate the re-excision rate for close (<3mm) or positive margins

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Surgery followed by RFAExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation
2013
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
495 Previous Clinical Trials
150,266 Total Patients Enrolled
16 Trials studying Breast Cancer
1,091 Patients Enrolled for Breast Cancer
Angiodynamics, Inc.Industry Sponsor
25 Previous Clinical Trials
2,749 Total Patients Enrolled
Daniela Ochoa, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Media Library

Surgery followed by RFA Clinical Trial Eligibility Overview. Trial Name: NCT01153035 — N/A
Breast Cancer Research Study Groups: Surgery followed by RFA
Breast Cancer Clinical Trial 2023: Surgery followed by RFA Highlights & Side Effects. Trial Name: NCT01153035 — N/A
Surgery followed by RFA 2023 Treatment Timeline for Medical Study. Trial Name: NCT01153035 — N/A
~3 spots leftby Jun 2025
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