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ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer


N/A
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the re-excision rate for close (<3mm) or positive margins

Outcome Description:

How many patients must go back for re-excision of margins

Outcome Time Frame:

Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)

Safety Issue:

No

Principal Investigator

Suzanne Klimberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

104603

NCT ID:

NCT01153035

Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Breast Conservation Therapy
  • Lumpectomy
  • Radiofrequency Ablation
  • Radiation
  • Breast Neoplasms

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of ArizonaTucson, Arizona  85724
The University of Kansas Cancer CenterKansas City, Kansas  66160
Sharp Oncology (Comprehensive Breast Care of San Diego)San Diego, California  92123
ColumbiaNew York, New York  10032