Trial Outcomes & Findings for Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions (NCT NCT02086578)
NCT ID: NCT02086578
Last Updated: 2026-01-20
Results Overview
The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2
Results posted on
2026-01-20
Participant Flow
Participant milestones
| Measure |
IMRT to Temporary Expander
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
58
|
|
Overall Study
COMPLETED
|
42
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
Baseline characteristics by cohort
| Measure |
IMRT to Temporary Expander
n=42 Participants
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 Participants
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=37 Participants
|
54 years
n=44 Participants
|
54 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=37 Participants
|
58 Participants
n=44 Participants
|
100 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=37 Participants
|
53 Participants
n=44 Participants
|
93 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
8 Participants
n=44 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=37 Participants
|
39 Participants
n=44 Participants
|
69 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=37 Participants
|
7 Participants
n=44 Participants
|
12 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=37 Participants
|
58 Participants
n=44 Participants
|
100 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).
Outcome measures
| Measure |
IMRT to Temporary Expander
n=42 Participants
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 Participants
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Incidence of Implant Failure
No Implant Failure
|
34 Number of Participants with Implant Fail
|
41 Number of Participants with Implant Fail
|
|
Incidence of Implant Failure
Implant Failure
|
8 Number of Participants with Implant Fail
|
17 Number of Participants with Implant Fail
|
SECONDARY outcome
Timeframe: 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2Will be examined using number of participants who developed Baker's grade \<2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered. Participants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant). Significant capsular contracture is measured as Baker grade III or IV.
Outcome measures
| Measure |
IMRT to Temporary Expander
n=42 Participants
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 Participants
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Incidence of Moderate to Severe Capsular Contracture
Grade IA-II Capsular Contracture
|
26 Participants
|
36 Participants
|
|
Incidence of Moderate to Severe Capsular Contracture
Grade III-IV Capsular Contracture
|
16 Participants
|
11 Participants
|
|
Incidence of Moderate to Severe Capsular Contracture
No Capsular Contracture
|
0 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 yearsIncidence of minor revisional surgeries by plastic surgeon will be evaluated by proportions too. Again, the rates (proportions) will be compared across the two groups.
Outcome measures
| Measure |
IMRT to Temporary Expander
n=42 Participants
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 Participants
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Rates of Minor Revisional Surgeries
Participants with minor surgical corrections
|
0 Participants
|
2 Participants
|
|
Rates of Minor Revisional Surgeries
Participants without minor surgical corrections
|
42 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo))To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time. With a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome. Each subtheme will be evaluated using one or more scales. Each scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life.
Outcome measures
| Measure |
IMRT to Temporary Expander
n=42 Participants
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 Participants
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Evaluate Cosmesis
Baseline Physical Well Being Abdomen
|
84 scores on a scale
Interval 76.0 to 92.0
|
64 scores on a scale
Interval 59.0 to 92.0
|
|
Evaluate Cosmesis
Follow-up 1 Physical Well Being Abdomen-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
70 scores on a scale
Interval 53.0 to 74.0
|
59 scores on a scale
Interval 47.0 to 70.0
|
|
Evaluate Cosmesis
Follow-up 2 Physical Well Being Abdomen-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
76 scores on a scale
Interval 62.0 to 79.0
|
69 scores on a scale
Interval 46.0 to 82.0
|
|
Evaluate Cosmesis
Follow-up 3 Physical Well Being Abdomen-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
69 scores on a scale
Interval 45.0 to 72.0
|
50 scores on a scale
Interval 0.0 to 75.0
|
|
Evaluate Cosmesis
Baseline Physical Well Being Chest
|
68 scores on a scale
Interval 58.0 to 83.0
|
60 scores on a scale
Interval 55.0 to 67.0
|
|
Evaluate Cosmesis
Follow-up 1 Physical Well Being Chest-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
61 scores on a scale
Interval 50.0 to 74.0
|
63 scores on a scale
Interval 53.0 to 84.0
|
|
Evaluate Cosmesis
Follow-up 2 Physical Well Being Chest-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
66 scores on a scale
Interval 57.0 to 85.0
|
72 scores on a scale
Interval 58.0 to 81.0
|
|
Evaluate Cosmesis
Follow-up 3 Physical Well Being Chest-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
68 scores on a scale
Interval 50.0 to 88.0
|
68 scores on a scale
Interval 60.0 to 92.0
|
|
Evaluate Cosmesis
Baseline Psychosocial Well Being
|
63 scores on a scale
Interval 50.0 to 67.0
|
67 scores on a scale
Interval 52.0 to 84.0
|
|
Evaluate Cosmesis
Follow-up 1 Psychosocial Well Being-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
63 scores on a scale
Interval 53.0 to 82.0
|
67 scores on a scale
Interval 50.0 to 86.0
|
|
Evaluate Cosmesis
Follow-up 2 Psychosocial Well Being-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
63 scores on a scale
Interval 52.0 to 70.0
|
63 scores on a scale
Interval 48.0 to 77.0
|
|
Evaluate Cosmesis
Follow-up 3 Psychosocial Well Being-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
62 scores on a scale
Interval 50.0 to 68.0
|
70 scores on a scale
Interval 52.0 to 100.0
|
|
Evaluate Cosmesis
Baseline Satisfaction with Breasts
|
58 scores on a scale
Interval 52.0 to 66.0
|
52 scores on a scale
Interval 42.0 to 62.0
|
|
Evaluate Cosmesis
Follow-up 1 Satisfaction with Breasts-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
59 scores on a scale
Interval 48.0 to 79.0
|
59 scores on a scale
Interval 48.0 to 79.0
|
|
Evaluate Cosmesis
Follow-up 2 Satisfaction with Breasts-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
52 scores on a scale
Interval 44.0 to 73.0
|
48 scores on a scale
Interval 40.0 to 74.0
|
|
Evaluate Cosmesis
Follow-up 3 Satisfaction with Breasts-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
50 scores on a scale
Interval 43.0 to 60.0
|
58 scores on a scale
Interval 39.0 to 78.0
|
|
Evaluate Cosmesis
Baseline Satisfaction with Outcome
|
67 scores on a scale
Interval 60.0 to 69.0
|
67 scores on a scale
Interval 47.0 to 75.0
|
|
Evaluate Cosmesis
Follow-up 1 Satisfaction with Outcome-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
67 scores on a scale
Interval 50.0 to 75.0
|
67 scores on a scale
Interval 57.0 to 75.0
|
|
Evaluate Cosmesis
Follow-up 2 Satisfaction with Outcome-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
61 scores on a scale
Interval 47.0 to 75.0
|
61 scores on a scale
Interval 47.0 to 75.0
|
|
Evaluate Cosmesis
Follow-up 3 Satisfaction with Outcome-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
0 scores on a scale
Interval 0.0 to 0.0
|
55 scores on a scale
Interval 40.0 to 70.0
|
|
Evaluate Cosmesis
Baseline Sexual Well Being
|
51 scores on a scale
Interval 46.0 to 56.0
|
43 scores on a scale
Interval 34.0 to 55.0
|
|
Evaluate Cosmesis
Follow-up 1 Sexual Well Being-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)
|
45 scores on a scale
Interval 36.0 to 52.0
|
47 scores on a scale
Interval 38.0 to 52.0
|
|
Evaluate Cosmesis
Follow-up 2 Sexual Well Being-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)
|
45 scores on a scale
Interval 37.0 to 52.0
|
39 scores on a scale
Interval 32.0 to 60.0
|
|
Evaluate Cosmesis
Follow-up 3 Sexual Well Being-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)
|
41 scores on a scale
Interval 27.0 to 50.0
|
48 scores on a scale
Interval 27.0 to 66.0
|
Adverse Events
IMRT to Temporary Expander
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
IMRT to Permanent Implant
Serious events: 15 serious events
Other events: 58 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
IMRT to Temporary Expander
n=42 participants at risk
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 participants at risk
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Infections and infestations
Breast infection
|
2.4%
1/42 • 2 years
|
12.1%
7/58 • 2 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/42 • 2 years
|
3.4%
2/58 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.4%
1/42 • 2 years
|
0.00%
0/58 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Infections and infestations
Skin infection
|
2.4%
1/42 • 2 years
|
0.00%
0/58 • 2 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.4%
1/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/42 • 2 years
|
3.4%
2/58 • 2 years
|
Other adverse events
| Measure |
IMRT to Temporary Expander
n=42 participants at risk
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
IMRT to Permanent Implant
n=58 participants at risk
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Breast MRI
Breast-Q© questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Investigations
White blood cell decreased
|
16.7%
7/42 • 2 years
|
27.6%
16/58 • 2 years
|
|
Investigations
Neutrophil count decreased
|
4.8%
2/42 • 2 years
|
12.1%
7/58 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
54.8%
23/42 • 2 years
|
56.9%
33/58 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/42 • 2 years
|
10.3%
6/58 • 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/42 • 2 years
|
6.9%
4/58 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/42 • 2 years
|
5.2%
3/58 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/42 • 2 years
|
1.7%
1/58 • 2 years
|
Additional Information
Dr. Daphna Gelblum, MD
Memorial Sloan Kettering Cancer Center
Phone: 914-367-7273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place