Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): 3D-Conformal External Beam
Intervention type(s): Radiation
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; invasive lobular breast carcinoma; tubular ductal breast carcinoma; mucinous ductal breast carcinoma; ductal breast carcinoma in situ; lobular breast carcinoma in situ; recurrent breast cancer