Trial Outcomes & Findings for Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations (NCT NCT02917421)
NCT ID: NCT02917421
Last Updated: 2025-05-04
Results Overview
feasibility of accelerated radiotherapy in the post-operative setting of breast cancer patients treated by neo-adjuvant chemotherapy and surgery will be measured, by evaluating the number of patients who experience grade II-III dermatitis within 60 days of the end of treatment. Acute Toxicity will be graded using CTCAE v4.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
60 days from start of radiation therapy.
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Cohort 1
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
41
|
|
Overall Study
COMPLETED
|
47
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Baseline characteristics by cohort
| Measure |
Cohort 1
n=47 Participants
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
n=41 Participants
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
41 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 days from start of radiation therapy.feasibility of accelerated radiotherapy in the post-operative setting of breast cancer patients treated by neo-adjuvant chemotherapy and surgery will be measured, by evaluating the number of patients who experience grade II-III dermatitis within 60 days of the end of treatment. Acute Toxicity will be graded using CTCAE v4.0.
Outcome measures
| Measure |
Cohort 1
n=47 Participants
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
n=41 Participants
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
|---|---|---|
|
Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, end of radiation, 1 month post radiation.Population: Data in the table is representative of those participants who completed the questionnaires.
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic and functional outcomes after breast radiation therapy. The score value ranges from 1.00 - 4.00, with a higher score reflecting a poorer outcome. Following is the criteria for evaluating breast radiation therapy outcomes in patients: good (1.00-1.75) ; intermediate (1.76-2.50), fair (2.51 -3.25) and poor (3.26 - 4.00).
Outcome measures
| Measure |
Cohort 1
n=46 Participants
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
n=37 Participants
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
|---|---|---|
|
Change in Quality of Life of Patients.
Baseline
|
1.62 score on a scale
Standard Deviation 0.730
|
1.92 score on a scale
Standard Deviation 0.979
|
|
Change in Quality of Life of Patients.
End of Radiation
|
1.80 score on a scale
Standard Deviation 0.876
|
1.82 score on a scale
Standard Deviation 0.855
|
|
Change in Quality of Life of Patients.
1 month post radiation
|
1.59 score on a scale
Standard Deviation 0.730
|
1.79 score on a scale
Standard Deviation 0.812
|
SECONDARY outcome
Timeframe: 2 years and 5 yearsincidence of late radiation toxicity (brachial plexopathy, fibrosis and telangiectasia) will be evaluated and genetic determinants of breast fibrosis will be identified.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years and 5 yearsNumber of patients with grades 2 or higher toxicity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe patient reported outcomes or quality of life questionnaires are assessed for the aesthetic and functional outcomes after breast radiation therapy. The score value ranges from 1.00 - 4.00, with a higher score reflecting a poorer outcome. Following is the criteria for evaluating breast radiation therapy outcomes in patients: good (1.00-1.75) ; intermediate (1.76-2.50), fair (2.51 -3.25) and poor (3.26 - 4.00).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 yearsThe purpose of this portion of the study will be to collect blood from each subject accrued to the study and willing to donate a specimen of blood for research, to study the TGF-β1 polymorphisms that have been reported to be correlated with the development of fibrosis following radiotherapy for treatment of breast cancer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 yearsOutcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 45 other events
Deaths: 47 deaths
Cohort 2
Serious events: 0 serious events
Other events: 41 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Cohort 1
n=47 participants at risk
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
n=41 participants at risk
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
|---|---|---|
|
Infections and infestations
Fever
|
2.1%
1/47 • Baseline, 60 days, 2 years and 5 years.
|
0.00%
0/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Surgical and medical procedures
Surgery Wound Infection
|
2.1%
1/47 • Baseline, 60 days, 2 years and 5 years.
|
0.00%
0/41 • Baseline, 60 days, 2 years and 5 years.
|
Other adverse events
| Measure |
Cohort 1
n=47 participants at risk
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
Cohort 2
n=41 participants at risk
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)
Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Radiation: (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction):
Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.4%
3/47 • Baseline, 60 days, 2 years and 5 years.
|
7.3%
3/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, Radiation
|
6.4%
3/47 • Baseline, 60 days, 2 years and 5 years.
|
7.3%
3/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.5%
4/47 • Baseline, 60 days, 2 years and 5 years.
|
24.4%
10/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Musculoskeletal and connective tissue disorders
Lymphedema
|
29.8%
14/47 • Baseline, 60 days, 2 years and 5 years.
|
22.0%
9/41 • Baseline, 60 days, 2 years and 5 years.
|
|
General disorders
Fatigue
|
44.7%
21/47 • Baseline, 60 days, 2 years and 5 years.
|
39.0%
16/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
3/47 • Baseline, 60 days, 2 years and 5 years.
|
4.9%
2/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Reproductive system and breast disorders
Breast Pain
|
8.5%
4/47 • Baseline, 60 days, 2 years and 5 years.
|
7.3%
3/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Vascular disorders
Hot Flashes
|
6.4%
3/47 • Baseline, 60 days, 2 years and 5 years.
|
0.00%
0/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Nervous system disorders
Anxiety
|
6.4%
3/47 • Baseline, 60 days, 2 years and 5 years.
|
0.00%
0/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
4.3%
2/47 • Baseline, 60 days, 2 years and 5 years.
|
9.8%
4/41 • Baseline, 60 days, 2 years and 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
4.3%
2/47 • Baseline, 60 days, 2 years and 5 years.
|
9.8%
4/41 • Baseline, 60 days, 2 years and 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place