Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

During the past ten years the Breast Cancer Radiotherapy Research team at NYU has conducted a series of consecutive studies to optimize the safe delivery of accelerated radiotherapy to partial and whole breast in the prone position, as summarized in a recent review of this experience. The current protocol focuses on whole breast radiotherapy for women with stage 0-2 breast cancer treated by segmental mastectomy: it aims at further refining the role of prone IMRT versus a 3D-conformal radiotherapy technique in this common subset of patients.

This study is an open label randomized trial. Patients will be randomized within cohort defined by assigned treatment (3D CRT if IMRT not covered or IMRT) and within these primary strata by menopausal status (pre/post) and by chemotherapy prior to radiation (yes/no). The on-site treatment randomization assignments will done on site and treatment assignments will be provided to the Research Nurse after she has confirmed eligibility. Patients will be randomized within the primary strata based on presumed insurance coverage on consent to the study to allow simulation to proceed. Should the coverage change, then the patient will be re-randomized in the correct stratum and the initial randomization number will be retired with a notation that the initial stratification was revised and patient re-randomized.

Patients will have completed all breast surgical procedures prior to accrual into this protocol in order to establish eligibility criteria. Final pathology margins must be at least 1 mm in all directions to be eligible. The patient may undergo re-excision if the initial margins are involved or close (< 1mm). If the patient meets the eligibility criteria after re-excision, she may be entered onto the study.