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A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy


Phase 2
40 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

2-15 years

Safety Issue:

No

Principal Investigator

Dennis Carter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Cancer Centers

Authority:

United States: Institutional Review Board

Study ID:

WIRB #20040075

NCT ID:

NCT01185145

Start Date:

February 2004

Completion Date:

August 2024

Related Keywords:

  • Breast Cancer
  • breast-conservation
  • accelerated partial breast irradiation
  • APBI
  • IMRT
  • Intensity modulated radiotherapy
  • breast brachytherapy
  • lumpectomy
  • early stage breast cancer
  • DCIS
  • Mammosite
  • Breast Neoplasms

Name

Location
Rocky Mountain Cancer Centers - Thornton Thornton, Colorado  80229
Rocky Mountain Cancer Centers - Midtown Denver, Colorado  80218
Rocky Mountain Cancer Centers - Aurora Aurora, Colorado  80012
Rocky Mountain Cancer Centers - Littleton Littleton, Colorado  80120
Rocky Mountain Cancer Centers - Boulder Boulder, Colorado  80303
Rocky Mountain Cancer Centers - Sky Ridge Lone Tree, Colorado  80124