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

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.

Study Overview

• Status: Terminated
• Conditions: IORT-Intra-Operative Radiation Therapy
• Intervention / Treatment: Radiation: Intraoperative Radiotherapy; Procedure: Oncoplastic partial mastectomy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-arm; Intraoperative Radiotherapy (Xoft, 20 Gy single dose)	Radiation: Intraoperative Radiotherapy; Intraoperative Radiotherapy (Xoft, 20 Gy single dose); Procedure: Oncoplastic partial mastectomy; Breast Conserving Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.	The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.	5 years
Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.	Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.	5 years
Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale	Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.	5 years
Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.	Data for perioperative complications will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of partial mastectomy with IORT, measured by local recurrence.	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.	5 years
Effectiveness of partial mastectomy with IORT, measured by regional recurrence.	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.	5 years
Effectiveness of partial mastectomy with IORT, measured by distant recurrence.	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.	5 years
Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.	Mastectomy rate will be measured by counting those who receive IORT and whose final pathology shows node positive or multifocal disease span >3cm post IORT, are advised to have mastectomy and have mastectomy.	5 years
Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.	Disease specific survival will be measured based on dates and causes of death.	5 years
Effectiveness of partial mastectomy with IORT, measured by overall survival	Overall survival will be measured based on dates and causes of death.	5 years

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Investigators: Principal Investigator: Janie L Weng Grumley, MD, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: JWCI OBCS WITH IORT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No