This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
PRIMARY OBJECTIVES: I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy. SECONDARY OBJECTIVES: I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire. III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs. OUTLINE: Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy. After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Undergo IOERT boost
Undergo lumpectomy
Ancillary studies
Ancillary studies
Undergo whole breast radiation therapy
Undergo oncoplastic reconstruction
University of North Carolina
Chapel Hill, North Carolina, United States
University Hospitals
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Centre Hospitalier de I'Universite de Montreal
Québec, Montreal, Canada
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Time frame: Up to 30 days after surgery and IOERT boost
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
Time frame: At 1 year from the end of therapy
Change in self-reported cosmesis using the BCTOS
The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.
Time frame: Baseline up to 3 years
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
Time frame: Up to 3 years after completion of radiation therapy
Quality of life assessed by Breast Cancer Treatment Outcome Scale
determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
Time frame: Up to 3 years after completion of radiation therapy
Rate of ipsilateral breast tumor recurrence
The exact binomial confidence interval for the rate will be calculated.
Time frame: At 5 years
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