Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
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.
Other: circulating tumor cell analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal accelerated partial breast irradiation
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma|
- Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year [ Designated as safety issue: Yes ]
- In-breast recurrence [ Designated as safety issue: No ]
- Freedom from mastectomy [ Designated as safety issue: No ]
- Rate of circulating tumor cells [ Designated as safety issue: No ]
- Overall and 1-year adverse events [ Designated as safety issue: Yes ]
- Cosmesis at 1 and 3 years [ Designated as safety issue: No ]
- Distant metastasis-free survival [ Designated as safety issue: No ]
- Mastectomy-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
- 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.
- To evaluate the adverse events at 1 year and at any time of this regimen in these patients.
- 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.