PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

external beams radiotherapy: External beam radiation therapy uses high doses of radiation to destroy cancer cells and shrink tumors. A large machine aims radiation at the cancer. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours).

brachytherapy: Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.

Study summary

Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.

Eligibility

Primary outcome measure(s)

• Local Control rate — 5 years
  Absence of the occurrence of new lump in the irradiated breast or appearance of skin lesions; it will be divided in inside or outside the treated area, evaluating the localization in the breast. For the evaluation it will be used bilateral mammography.

Trial sites (1)

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