Status:
COMPLETED
Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal...
Detailed Description
OBJECTIVES: Primary * Determine the effectiveness of radiofrequency ablation (RFA), in terms of amount of tumor coagulated and viable cell count, in patients with early invasive breast cancer or low...
Eligibility Criteria
Inclusion
- Females of ages ≥18 years.
- Core biopsy proven invasive breast cancer OR
- Core biopsy proven low or intermediate grade DCIS.
- Tumor less than or equal to 2.0 cm in diameter.
- No prior surgical treatment for breast cancer within 30 days.
- Life expectancy of \> 10 years, not including the diagnosis of cancer.
- ECOG performance status of 0-2.
- Informed consent given.
- Multifocal invasive breast cancer patients are eligible. All tumors that are palpable or visualized by USS can be treated.
Exclusion
- Male subjects.
- Ages \< 18 years.
- Breast tumor \> 2.0 cm in diameter.
- Evidence of distant metastatic disease.
- Evidence of diffuse calcification suggestive of extensive or multifocal DCIS.
- High grade DCIS or presence of comedo-necrosis because these lesions can be associated with invasive breast cancer, which would go undetected if the lesion is entirely destroyed by the RF ablation.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00388115
Start Date
October 1 2001
End Date
May 1 2007
Last Update
March 29 2010
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817