Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy (APBI)

Rocky Mountain Cancer Centers

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: Intensity Modulated Radiotherapy; Radiation: Breast Brachytherapy with Mammosite RTS

Study type: Interventional

Funder types: Other

Identifiers

NCT01185145

WIRB #20040075

Details and patient eligibility

About

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

Enrollment: 291 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

Mammosite

Experimental group

Description:

Accelerated Partial Breast Irradiation using Mammosite RTS

Treatment:

Radiation: Breast Brachytherapy with Mammosite RTS

IMRT

Experimental group

Description:

Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Treatment:

Radiation: Intensity Modulated Radiotherapy