Trial Outcomes & Findings for Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma (NCT NCT03422003)
NCT ID: NCT03422003
Last Updated: 2024-11-01
Results Overview
The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life. Score ranges: * The score range for the FACT-B total score is 0-148. * The score range for the PWB, social/family well-being (SWB), and functional well-being (FWB) subscales is 0-28. * The score range for the emotional well-being (EWB) subscale is 0-24. * The score range for the breast cancer subscale (BCS) is 0-40.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
6 months
Results posted on
2024-11-01
Participant Flow
The following are reasons for withdrawal from the study before starting protocol treatment: * patients withdrew due to the treatment arm assignment * patients withdrew due to a change in treatment site * clinician withdrew patients due to tissue expander removal and other treatment needs
Participant milestones
| Measure |
Arm 1: Hypofractionation
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
|---|---|---|
|
Baseline
STARTED
|
199
|
201
|
|
Baseline
COMPLETED
|
192
|
199
|
|
Baseline
NOT COMPLETED
|
7
|
2
|
|
6-month Follow-up
STARTED
|
192
|
199
|
|
6-month Follow-up
COMPLETED
|
166
|
166
|
|
6-month Follow-up
NOT COMPLETED
|
26
|
33
|
Reasons for withdrawal
| Measure |
Arm 1: Hypofractionation
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
|---|---|---|
|
Baseline
Some participants skipped the survey question related to the primary outcome being analyzed.
|
7
|
2
|
|
6-month Follow-up
Withdrawal by subject, loss to follow-up
|
26
|
33
|
Baseline Characteristics
Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
Baseline characteristics by cohort
| Measure |
Arm 1: Hypofractionation
n=199 Participants
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
n=201 Participants
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · <40 years
|
42 Participants
n=199 Participants
|
41 Participants
n=201 Participants
|
83 Participants
n=400 Participants
|
|
Age, Customized
Age · 40-50 years
|
84 Participants
n=199 Participants
|
90 Participants
n=201 Participants
|
174 Participants
n=400 Participants
|
|
Age, Customized
Age · 51-60 years
|
49 Participants
n=199 Participants
|
42 Participants
n=201 Participants
|
91 Participants
n=400 Participants
|
|
Age, Customized
Age · 60+ years
|
19 Participants
n=199 Participants
|
19 Participants
n=201 Participants
|
38 Participants
n=400 Participants
|
|
Age, Customized
Age · Missing
|
5 Participants
n=199 Participants
|
9 Participants
n=201 Participants
|
14 Participants
n=400 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=199 Participants
|
201 Participants
n=201 Participants
|
400 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=199 Participants
|
27 Participants
n=201 Participants
|
46 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=199 Participants
|
174 Participants
n=201 Participants
|
354 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=199 Participants
|
12 Participants
n=201 Participants
|
33 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=199 Participants
|
8 Participants
n=201 Participants
|
14 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=199 Participants
|
161 Participants
n=201 Participants
|
318 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=199 Participants
|
20 Participants
n=201 Participants
|
35 Participants
n=400 Participants
|
|
Region of Enrollment
United States
|
199 participants
n=199 Participants
|
201 participants
n=201 Participants
|
400 participants
n=400 Participants
|
|
Education
No College
|
20 Participants
n=199 Participants
|
29 Participants
n=201 Participants
|
49 Participants
n=400 Participants
|
|
Education
Some college
|
32 Participants
n=199 Participants
|
42 Participants
n=201 Participants
|
74 Participants
n=400 Participants
|
|
Education
College graduate
|
63 Participants
n=199 Participants
|
57 Participants
n=201 Participants
|
120 Participants
n=400 Participants
|
|
Education
Some graduate/graduate degree
|
80 Participants
n=199 Participants
|
72 Participants
n=201 Participants
|
152 Participants
n=400 Participants
|
|
Education
Missing
|
4 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
5 Participants
n=400 Participants
|
|
BMI
<20 (kg/m^2)
|
18 Participants
n=199 Participants
|
11 Participants
n=201 Participants
|
29 Participants
n=400 Participants
|
|
BMI
20.0-24.9 (kg/m^2)
|
79 Participants
n=199 Participants
|
75 Participants
n=201 Participants
|
154 Participants
n=400 Participants
|
|
BMI
25.0-29.9 (kg/m^2)
|
55 Participants
n=199 Participants
|
60 Participants
n=201 Participants
|
115 Participants
n=400 Participants
|
|
BMI
30.0-34.9 (kg/m^2)
|
30 Participants
n=199 Participants
|
34 Participants
n=201 Participants
|
64 Participants
n=400 Participants
|
|
BMI
Greater than or equal to 35.0 (kg/m^2)
|
16 Participants
n=199 Participants
|
20 Participants
n=201 Participants
|
36 Participants
n=400 Participants
|
|
BMI
Missing
|
1 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
2 Participants
n=400 Participants
|
|
Smoking Status
Never Smoked
|
147 Participants
n=199 Participants
|
140 Participants
n=201 Participants
|
287 Participants
n=400 Participants
|
|
Smoking Status
Current/Former Smoker
|
52 Participants
n=199 Participants
|
61 Participants
n=201 Participants
|
113 Participants
n=400 Participants
|
|
Prior Infection
No
|
188 Participants
n=199 Participants
|
187 Participants
n=201 Participants
|
375 Participants
n=400 Participants
|
|
Prior Infection
Yes
|
11 Participants
n=199 Participants
|
14 Participants
n=201 Participants
|
25 Participants
n=400 Participants
|
|
Cancer Laterality
Laterality: Right
|
113 Participants
n=199 Participants
|
93 Participants
n=201 Participants
|
206 Participants
n=400 Participants
|
|
Cancer Laterality
Laterality: Left
|
86 Participants
n=199 Participants
|
107 Participants
n=201 Participants
|
193 Participants
n=400 Participants
|
|
Cancer Laterality
Missing
|
0 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
1 Participants
n=400 Participants
|
|
Hormone Receptor Status
Positive
|
162 Participants
n=199 Participants
|
174 Participants
n=201 Participants
|
336 Participants
n=400 Participants
|
|
Hormone Receptor Status
Negative
|
37 Participants
n=199 Participants
|
27 Participants
n=201 Participants
|
64 Participants
n=400 Participants
|
|
HER2 Status
Equivocal
|
11 Participants
n=199 Participants
|
11 Participants
n=201 Participants
|
22 Participants
n=400 Participants
|
|
HER2 Status
Negative
|
146 Participants
n=199 Participants
|
149 Participants
n=201 Participants
|
295 Participants
n=400 Participants
|
|
HER2 Status
Positive
|
42 Participants
n=199 Participants
|
39 Participants
n=201 Participants
|
81 Participants
n=400 Participants
|
|
HER2 Status
Unknown
|
0 Participants
n=199 Participants
|
2 Participants
n=201 Participants
|
2 Participants
n=400 Participants
|
|
Histology
Invasive Ductal
|
139 Participants
n=199 Participants
|
147 Participants
n=201 Participants
|
286 Participants
n=400 Participants
|
|
Histology
Invasive Lobular
|
29 Participants
n=199 Participants
|
32 Participants
n=201 Participants
|
61 Participants
n=400 Participants
|
|
Histology
Both
|
25 Participants
n=199 Participants
|
14 Participants
n=201 Participants
|
39 Participants
n=400 Participants
|
|
Histology
Other
|
6 Participants
n=199 Participants
|
8 Participants
n=201 Participants
|
14 Participants
n=400 Participants
|
|
Tumor Grade
Poorly Differentiated (Grade 3)
|
82 Participants
n=199 Participants
|
78 Participants
n=201 Participants
|
160 Participants
n=400 Participants
|
|
Tumor Grade
Moderately Differentiated (Grade 2)
|
95 Participants
n=199 Participants
|
96 Participants
n=201 Participants
|
191 Participants
n=400 Participants
|
|
Tumor Grade
Well Differentiated (Grade 1)
|
20 Participants
n=199 Participants
|
26 Participants
n=201 Participants
|
46 Participants
n=400 Participants
|
|
Tumor Grade
Not applicable
|
2 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
3 Participants
n=400 Participants
|
|
Tumor Size
Less than or equal to 2 cm
|
99 Participants
n=199 Participants
|
114 Participants
n=201 Participants
|
213 Participants
n=400 Participants
|
|
Tumor Size
Greater than 2 cm - Less than or equal to 5 cm
|
60 Participants
n=199 Participants
|
49 Participants
n=201 Participants
|
109 Participants
n=400 Participants
|
|
Tumor Size
Greater than 5cm
|
21 Participants
n=199 Participants
|
23 Participants
n=201 Participants
|
44 Participants
n=400 Participants
|
|
Tumor Size
Missing
|
19 Participants
n=199 Participants
|
15 Participants
n=201 Participants
|
34 Participants
n=400 Participants
|
|
Lymphatic Vessel Invasion (LVI)
Negative
|
118 Participants
n=199 Participants
|
126 Participants
n=201 Participants
|
244 Participants
n=400 Participants
|
|
Lymphatic Vessel Invasion (LVI)
Other
|
79 Participants
n=199 Participants
|
73 Participants
n=201 Participants
|
152 Participants
n=400 Participants
|
|
Lymphatic Vessel Invasion (LVI)
Missing
|
2 Participants
n=199 Participants
|
2 Participants
n=201 Participants
|
4 Participants
n=400 Participants
|
|
Total number of positive nodes
0 nodes
|
56 Participants
n=199 Participants
|
52 Participants
n=201 Participants
|
108 Participants
n=400 Participants
|
|
Total number of positive nodes
1 node
|
65 Participants
n=199 Participants
|
76 Participants
n=201 Participants
|
141 Participants
n=400 Participants
|
|
Total number of positive nodes
2 nodes
|
33 Participants
n=199 Participants
|
32 Participants
n=201 Participants
|
65 Participants
n=400 Participants
|
|
Total number of positive nodes
3 or more nodes
|
38 Participants
n=199 Participants
|
34 Participants
n=201 Participants
|
72 Participants
n=400 Participants
|
|
Total number of positive nodes
Missing
|
7 Participants
n=199 Participants
|
7 Participants
n=201 Participants
|
14 Participants
n=400 Participants
|
|
Axillary Node Dissection
No
|
99 Participants
n=199 Participants
|
112 Participants
n=201 Participants
|
211 Participants
n=400 Participants
|
|
Axillary Node Dissection
Yes
|
100 Participants
n=199 Participants
|
89 Participants
n=201 Participants
|
189 Participants
n=400 Participants
|
|
Axillary Nodes Removed
|
8.5 Nodes
n=199 Participants
|
9.0 Nodes
n=201 Participants
|
9 Nodes
n=400 Participants
|
|
Location of Device
Pre-pectoral
|
115 Participants
n=199 Participants
|
118 Participants
n=201 Participants
|
233 Participants
n=400 Participants
|
|
Location of Device
Sub-pectoral
|
84 Participants
n=199 Participants
|
79 Participants
n=201 Participants
|
163 Participants
n=400 Participants
|
|
Location of Device
Not applicable/Unknown
|
0 Participants
n=199 Participants
|
4 Participants
n=201 Participants
|
4 Participants
n=400 Participants
|
|
Device irradiated
Expander
|
160 Participants
n=199 Participants
|
156 Participants
n=201 Participants
|
316 Participants
n=400 Participants
|
|
Device irradiated
Implant
|
39 Participants
n=199 Participants
|
45 Participants
n=201 Participants
|
84 Participants
n=400 Participants
|
|
Neoadjuvant Chemotherapy
Yes
|
137 Participants
n=199 Participants
|
134 Participants
n=201 Participants
|
271 Participants
n=400 Participants
|
|
Neoadjuvant Chemotherapy
No
|
62 Participants
n=199 Participants
|
67 Participants
n=201 Participants
|
129 Participants
n=400 Participants
|
|
Neoadjuvant Chemotherapy
Unknown
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Neoadjuvant endocrine therapy
Yes
|
46 Participants
n=199 Participants
|
39 Participants
n=201 Participants
|
85 Participants
n=400 Participants
|
|
Neoadjuvant endocrine therapy
No
|
152 Participants
n=199 Participants
|
162 Participants
n=201 Participants
|
314 Participants
n=400 Participants
|
|
Neoadjuvant endocrine therapy
Unknown
|
1 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=400 Participants
|
|
Radiation Therapy
Chest Wall and Nodes
|
170 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
160 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
330 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Radiation Therapy
Chest Wall alone
|
19 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
23 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
42 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Radiation Therapy
Missing due to study withdrawal
|
5 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
9 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
14 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Technique
IMRT
|
82 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
78 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
160 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Technique
3D-Conformal
|
109 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
112 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
221 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Technique
Missing
|
3 Participants
n=194 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
2 Participants
n=192 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
5 Participants
n=386 Participants • Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.
|
|
Time from surgery to RT (months) (Median, Q1, Q3)
|
2.7 Months
n=199 Participants
|
2.4 Months
n=201 Participants
|
2.5 Months
n=400 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Some participants skipped the survey questions related to the primary outcome being analyzed. This is why there is a discrepancy between the number analyzed for each domain and the total number of participants in each arm.
The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life. Score ranges: * The score range for the FACT-B total score is 0-148. * The score range for the PWB, social/family well-being (SWB), and functional well-being (FWB) subscales is 0-28. * The score range for the emotional well-being (EWB) subscale is 0-24. * The score range for the breast cancer subscale (BCS) is 0-40.
Outcome measures
| Measure |
Arm 1: Hypofractionation
n=199 Participants
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
n=201 Participants
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
|---|---|---|
|
Patient Reported Outcomes Using the FACT-B
6-month FACT-B
|
105.0 score on a scale
Standard Deviation 15.0
|
103.5 score on a scale
Standard Deviation 17.7
|
|
Patient Reported Outcomes Using the FACT-B
6-month PWB
|
23.0 score on a scale
Standard Deviation 4.1
|
22.4 score on a scale
Standard Deviation 4.7
|
|
Patient Reported Outcomes Using the FACT-B
6-month SWB
|
22.4 score on a scale
Standard Deviation 4.9
|
22.2 score on a scale
Standard Deviation 5.0
|
|
Patient Reported Outcomes Using the FACT-B
6-month EWB
|
16.5 score on a scale
Standard Deviation 3.2
|
16.1 score on a scale
Standard Deviation 3.8
|
|
Patient Reported Outcomes Using the FACT-B
Baseline FACT-B
|
104.3 score on a scale
Standard Deviation 14.5
|
102.4 score on a scale
Standard Deviation 17.0
|
|
Patient Reported Outcomes Using the FACT-B
Baseline PWB
|
22.4 score on a scale
Standard Deviation 5.0
|
22.5 score on a scale
Standard Deviation 4.7
|
|
Patient Reported Outcomes Using the FACT-B
Baseline SWB
|
23.8 score on a scale
Standard Deviation 4.1
|
23.0 score on a scale
Standard Deviation 4.6
|
|
Patient Reported Outcomes Using the FACT-B
Baseline EWB
|
16.2 score on a scale
Standard Deviation 2.8
|
15.8 score on a scale
Standard Deviation 3.5
|
|
Patient Reported Outcomes Using the FACT-B
Baseline FWB
|
16.7 score on a scale
Standard Deviation 4.4
|
16.3 score on a scale
Standard Deviation 4.8
|
|
Patient Reported Outcomes Using the FACT-B
Baseline BCS
|
25.3 score on a scale
Standard Deviation 4.6
|
24.9 score on a scale
Standard Deviation 5.2
|
|
Patient Reported Outcomes Using the FACT-B
6-month FWB
|
17.7 score on a scale
Standard Deviation 4.3
|
17.3 score on a scale
Standard Deviation 4.5
|
|
Patient Reported Outcomes Using the FACT-B
6-month BCS
|
25.4 score on a scale
Standard Deviation 4.7
|
25.4 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 10 yearsClinical and oncologic outcomes (rare radiation side effects, recurrence, infections, additional surgeries) will be assessed over a period of 10 years through annual medical record abstractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsCosmetic outcomes (quality of reconstructive surgery throughout and after radiation therapy) will be assessed from baseline to 18 months by trained physicians using a standardized rating scale.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Hypofractionation
Serious events: 37 serious events
Other events: 4 other events
Deaths: 2 deaths
Arm 2: Conventional Radiation Therapy
Serious events: 29 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1: Hypofractionation
n=199 participants at risk
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
n=201 participants at risk
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
|---|---|---|
|
General disorders
Distant recurrence
|
5.5%
11/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
6.0%
12/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
|
General disorders
Local-regional recurrence
|
0.50%
1/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
0.50%
1/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
3/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
0.50%
1/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
|
Infections and infestations
Infection
|
11.1%
22/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
7.0%
14/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
|
Blood and lymphatic system disorders
Lymphedema
|
0.00%
0/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
0.50%
1/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
Other adverse events
| Measure |
Arm 1: Hypofractionation
n=199 participants at risk
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
Arm 2: Conventional Radiation Therapy
n=201 participants at risk
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dehisence
|
1.5%
3/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
0.50%
1/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
|
Skin and subcutaneous tissue disorders
Capsular Contracture
|
0.50%
1/199 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
0.50%
1/201 • Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place