NCT01082211

Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.

Detailed description

OBJECTIVES: Primary * To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma. Secondary * To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time. * To evaluate in-breast control rate in patients treated with this regimen. * To evaluate freedom-from-mastectomy rate in these patients. * To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy. * To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival. * To evaluate cosmesis as judged by the patient and independent evaluation. * To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks. Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis. Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy. After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	3D-Conformal External Beam	Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-11-01
• Completion: 2022-05-20
• First posted: 2010-03-08
• Last updated: 2022-06-21
• Results posted: 2017-06-08

Locations

58 sites across 2 countries: United States, Canada