Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.
Age ≥ 50 y.o. Histologically proven in situ and invasive ductal or lobular breast recurrence Prior history of whole breast/chest wall radiation therapy Disease span ≤ 3 cm, unifocal No nodal disease (N0) No evidence of metastatic disease (M0) Time from initial BCT should be ≥ 1 year Patients have refused the standard of care of mastectomy Skin distance of ≥ 0.8 cm between applicator and skin
Exclusion Criteria:
Multifocal and/or multicenter recurrence
N1-3 status: Regional cytological or histologically proven node recurrence M1 status: Metastatic disease cT4 (Skin or muscle involvement) or Paget's disease of the nipple Patients undergoing mastectomy Patients undergoing neoadjuvant systemic therapy Connective tissue disease or scleroderma, contraindicating radiotherapy
