Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Description

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.

Conditions

IORT-Intra-Operative Radiation Therapy

Study Overview

Study Details

Study overview

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.

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Condition
IORT-Intra-Operative Radiation Therapy
Intervention / Treatment

-

Contacts and Locations

Santa Monica

Providence Saint John's Hospital, Santa Monica, California, United States, 90404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Saint John's Cancer Institute,

Janie L Weng Grumley, MD, PRINCIPAL_INVESTIGATOR, Saint John's Cancer Institute

Study Record Dates

2026-02