Trial Outcomes & Findings for Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer (NCT NCT02482376)
NCT ID: NCT02482376
Last Updated: 2026-03-17
Results Overview
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
ACTIVE_NOT_RECRUITING
PHASE2
110 participants
6 months
2026-03-17
Participant Flow
Women ages 60 or older with clinically node-negative, 2cm or less, biopsy proven ductal carcinoma in situ or invasive carcinoma seen in the Duke Radiation Oncology department were considered for this trial. Women age 50-59 with a cT1N0 tumor and a low Oncotype score were also eligible.
42 participants were withdrawn prior to starting study procedures due to insurance denial or ineligibility.
Participant milestones
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Data not collected on one participant.
Baseline characteristics by cohort
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=68 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 7 • n=68 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
|
Physician reported rates of good/excellent cosmesis
|
67 Participants
n=67 Participants • Data not collected on one participant.
|
|
Patient reported rates of good/excellent cosmesis
|
67 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPhysician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
|
64 Participants
|
PRIMARY outcome
Timeframe: 1 yearPhysician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
|
59 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Only participants whose physician completed the cosmesis evaluation are included.
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=67 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
|
58 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Only participants whose physician completed the cosmesis evaluation are included.
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=64 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis.
|
56 Participants
|
SECONDARY outcome
Timeframe: baselinePatients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
|
67 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPatients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
|
62 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPatients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
|
60 Participants
|
SECONDARY outcome
Timeframe: 2 yearPopulation: Only participants who completed the cosmesis evaluation are included.
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=67 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
|
60 Participants
|
SECONDARY outcome
Timeframe: 3 yearPopulation: Only participants who completed the cosmesis evaluation are included.
Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Outcome measures
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=64 Participants
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis
|
53 Participants
|
SECONDARY outcome
Timeframe: Through study completion estimated to be 10 yearsLocal control consists of annual clinical examination combined with breast imaging
Outcome measures
Outcome data not reported
Adverse Events
Single Arm 21Gy Stereotactic Radiotherapy
Serious adverse events
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 participants at risk
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
Injury, poisoning and procedural complications
seroma
|
1.5%
1/68 • Number of events 1 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
2.9%
2/68 • Number of events 2 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Injury, poisoning and procedural complications
Fibrous deep connective tissue
|
1.5%
1/68 • Number of events 1 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Reproductive system and breast disorders
volume loss
|
1.5%
1/68 • Number of events 1 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
Other adverse events
| Measure |
Single Arm 21Gy Stereotactic Radiotherapy
n=68 participants at risk
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
Stereotactic body radiotherapy ( SBRT): Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
|
|---|---|
|
General disorders
Fatigue
|
16.2%
11/68 • Number of events 13 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Infections and infestations
Breast infection
|
7.4%
5/68 • Number of events 5 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
29.4%
20/68 • Number of events 24 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications, other
|
22.1%
15/68 • Number of events 17 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Injury, poisoning and procedural complications
Seroma
|
39.7%
27/68 • Number of events 39 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
70.6%
48/68 • Number of events 52 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Reproductive system and breast disorders
Breast atrophy
|
5.9%
4/68 • Number of events 4 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Reproductive system and breast disorders
Breast pain
|
58.8%
40/68 • Number of events 59 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders, other
|
23.5%
16/68 • Number of events 20 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
4/68 • Number of events 4 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
22.1%
15/68 • Number of events 18 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
29.4%
20/68 • Number of events 24 • Adverse events will be collected over a 10 year period. Reported here at up to 3 years; to be updated at study completion.
|
Additional Information
Clinical Trials Office
Duke University Health System (DUHS)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place