Trial Outcomes & Findings for Radiation Therapy in Treating Patients With Recurrent Breast Cancer (NCT NCT00945061)

Last Updated: 2020-08-18

Results Overview

Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

1 month after radiation therapy (RT)

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Intraoperative Radiation Therapy Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Overall Study STARTED	12	1
Overall Study COMPLETED	12	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 month after radiation therapy (RT)

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 months after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 months after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 9 months after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 months after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	9 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	9 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	10 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 5 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=9 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Ipsilateral Breast Tumor Recurrence Rates	11 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 1 month after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 month after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 month after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 month after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	0 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 years after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	9 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 years after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	9 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	10 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 5 years after RT

Population: Evaluable participants enrolled in study

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=9 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Tumor Bed Recurrence Rates	11 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 1 month after RT & Q3mos for one year and at 5 years

Population: Participants who had data collected for survey. Only participants in group 1 completed survey.

Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes. Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=10 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months n=8 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month n=5 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months n=5 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years n=6 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Cosmetic Outcome as Determined by an Established Scale Fair	38 percentage of participants	50 percentage of participants	37 percentage of participants	75 percentage of participants	60 percentage of participants	60 percentage of participants	50 percentage of participants
Cosmetic Outcome as Determined by an Established Scale Poor	0 percentage of participants	0 percentage of participants	13 percentage of participants	0 percentage of participants	20 percentage of participants	10 percentage of participants	17 percentage of participants
Cosmetic Outcome as Determined by an Established Scale Excellent	8 percentage of participants	0 percentage of participants	13 percentage of participants	0 percentage of participants	0 percentage of participants	10 percentage of participants	0 percentage of participants
Cosmetic Outcome as Determined by an Established Scale Good	54 percentage of participants	50 percentage of participants	37 percentage of participants	25 percentage of participants	20 percentage of participants	20 percentage of participants	33 percentage of participants

PRIMARY outcome

Timeframe: 1 month after RT

Population: Evaluable participants enrolled in study

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 month after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 month after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 9 month after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 month after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	100 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 5 years after RT

Population: Evaluable participants enrolled in study

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=9 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey	100 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 1 month after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	33 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 month after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 month after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 9 month after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 month after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 years after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 years after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	36 percentage of participants	0 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 5 years after RT

Population: Evaluable participants enrolled in study

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants Experiencing Complications After Intervention	40 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 month after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	8 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 month after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 month after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 9 month after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 month after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 2 years after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 4 years after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=11 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	9 percentage of participants	0 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 years after RT

Population: Evaluable participants enrolled on study

Wound healing rate, as measured by percent of participants with delayed wound healing

Outcome measures

Outcome measures
Measure	Intraoperative Radiation Therapy n=10 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	3 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	6 Month Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	9 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12 Months Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	5 Years Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Percent of Participants With Delayed Wound Healing	10 percentage of participants	0 percentage of participants	—	—	—	—	—

Adverse Events

Intraoperative Radiation Therapy

Serious events: 0 serious events

Other events: 11 other events

Deaths: 1 deaths

Intracavitary Balloon Brachytherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intraoperative Radiation Therapy n=12 participants at risk Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 participants at risk Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Blood and lymphatic system disorders Hemoglobin	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Blood and lymphatic system disorders Hemorrhage, pulmonary/upper respiratory - nose	0.00% 0/12 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Cardiac disorders Hypertension	25.0% 3/12 • Number of events 3 • up to 5 years	0.00% 0/1 • up to 5 years
General disorders Fatigue	25.0% 3/12 • Number of events 4 • up to 5 years	0.00% 0/1 • up to 5 years
General disorders Insomnia	25.0% 3/12 • Number of events 4 • up to 5 years	0.00% 0/1 • up to 5 years
General disorders Rigors/chills	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Burn	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Breast indentation/dimpling	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Skin retraction	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Skin dimpling	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Hyperpigmentation	50.0% 6/12 • Number of events 9 • up to 5 years	100.0% 1/1 • Number of events 2 • up to 5 years
Skin and subcutaneous tissue disorders Induration/fibrosis (skin and subcutaneous tissue)	41.7% 5/12 • Number of events 5 • up to 5 years	100.0% 1/1 • Number of events 2 • up to 5 years
Skin and subcutaneous tissue disorders Nail changes	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Radiation	16.7% 2/12 • Number of events 2 • up to 5 years	100.0% 1/1 • Number of events 2 • up to 5 years
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	25.0% 3/12 • Number of events 4 • up to 5 years	0.00% 0/1 • up to 5 years
Skin and subcutaneous tissue disorders Telangiectasia	16.7% 2/12 • Number of events 2 • up to 5 years	100.0% 1/1 • Number of events 2 • up to 5 years
Endocrine disorders Hot flashes/flushes	25.0% 3/12 • Number of events 3 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Gastrointestinal disorders Colitis	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Gastrointestinal disorders Heartburn/dyspepsia	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Infections and infestations Breast Infection	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Blood and lymphatic system disorders Edema: limb	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Blood and lymphatic system disorders Edema: trunk/genital	25.0% 3/12 • Number of events 4 • up to 5 years	100.0% 1/1 • Number of events 2 • up to 5 years
Blood and lymphatic system disorders Lymphatics: seroma	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Extremity-lower (gait/walking)	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Fibrosis-cosmesis	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Fracture	8.3% 1/12 • Number of events 1 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Musculoskeletal and connective tissue disorders Joint-function	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Superficial soft tissue breast fibrosis	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Seroma	41.7% 5/12 • Number of events 6 • up to 5 years	0.00% 0/1 • up to 5 years
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Nervous system disorders Memory impairment	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Nervous system disorders Mood alteration - Depression	16.7% 2/12 • Number of events 3 • up to 5 years	0.00% 0/1 • up to 5 years
Nervous system disorders Neuropathy: sensory	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Back	25.0% 3/12 • Number of events 3 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Breast	8.3% 1/12 • Number of events 1 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Dental/teeth/peridontal	8.3% 1/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	16.7% 2/12 • Number of events 4 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Head/headache	25.0% 3/12 • Number of events 3 • up to 5 years	100.0% 1/1 • Number of events 1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Joint	33.3% 4/12 • Number of events 4 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Pelvis	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Musculoskeletal and connective tissue disorders Pain - Skin	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	16.7% 2/12 • Number of events 2 • up to 5 years	0.00% 0/1 • up to 5 years
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Reproductive system and breast disorders Breast nipple/areolar deformity	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Reproductive system and breast disorders Nipple Inversion	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years
Surgical and medical procedures Intra-operative injury - Skin	8.3% 1/12 • Number of events 1 • up to 5 years	0.00% 0/1 • up to 5 years

Additional Information

Dr. Janice A. Lyons, MD

University Hospitals Cleveland Medical Center , Case Comprehensive Cancer Center

Phone: +1 216-844-2536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intraoperative Radiation Therapy n=12 Participants Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Intracavitary Balloon Brachytherapy n=1 Participants Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	Total n=13 Participants Total of all reporting groups
Age, Customized 40-49 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 50-59 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized 60-69 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 70-79 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 80-89 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	1 participants n=7 Participants	13 participants n=5 Participants