NCT01185145
Unknown
Phase 2
A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
ConditionsBreast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Rocky Mountain Cancer Centers
- Enrollment
- 291
- Locations
- 6
- Primary Endpoint
- Overall Survival
- Last Updated
- 12 years ago
Overview
Brief Summary
Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be a Tis, T1, N0, M0 AJC Classification
- •Have negative surgical margins (\> or = 2 mm) after final surgery
- •Should have adequate skin spacing between balloon surface and surface the skin (\> 7 mm)\*
- •Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
- •Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.
Exclusion Criteria
- •Be pregnant or breast-feeding
- •Have collagen-vascular disease
- •Inadequate surgical margins (\< 2 mm)
- •Patients with malignant/suspicious calcifications
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 2-15 years
Ipsilateral breast failure
Time Frame: 2-15 years
Disease free survival
Time Frame: 2-15 years
Cause specific survival
Time Frame: 2-15 years
Secondary Outcomes
- Serious Adverse device-related Events(2-5 years)
Study Sites (6)
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