Breast Cancer Clinical Trial
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
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There is 1 Location for this study
Santa Monica California, 90404, United States More Info
Principal Investigator
Sub-Investigator
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