Trial Outcomes & Findings for A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca (NCT NCT02453737)
NCT ID: NCT02453737
Last Updated: 2024-09-19
Results Overview
Participants end up being rated as fair or poor cosmesis from baseline. Excellent: treated breast nearly identical to untreated breast Good: treated breast slightly different than untreated (minimal but identifiable effects of the treated breast) Fair: Treated breast clearly different from untreated but not seriously distorted (significant radiation effects readily observable) Poor: Treated breast seriously distorted (severe sequelae of breast tissue secondary to radiation effects)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Baseline, 3 years
Results posted on
2024-09-19
Participant Flow
170 Patients were registered, but 4 patients weren't assigned to a treatment.
Participant milestones
| Measure |
Catheter-based Brachytherapy APBI
7 Gy x 3 fractions
\>
\> Brachytherapy APBI
|
3D-CRT APBI
7.3 Gy x 3 fractions
* D-CRT (photon) APBI
|
Proton APBI
7.3 Gy x 3 fractions \>
\> Proton APBI
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
58
|
52
|
|
Overall Study
COMPLETED
|
56
|
56
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca
Baseline characteristics by cohort
| Measure |
Catheter-based Brachytherapy APBI
n=56 Participants
7 Gy x 3 fractions\>
\> Brachytherapy APBI
|
3D-CRT APBI
n=58 Participants
7.3 Gy x 3 fractions\>
\> 3D-CRT (photon) APBI
|
Proton APBI
n=52 Participants
7.3 Gy x 3 fractions\>
\> Proton APBI
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
66.2 years
n=7 Participants
|
67.4 years
n=5 Participants
|
66.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Laterality
Right
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Laterality
Left
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Histology (grouped)
DCIS
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Histology (grouped)
Invasive carcinoma
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Histology
IDC
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Histology
DCIS
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Histology
Mucinous
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Histology
ILC
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Histology
Invasive mammary carcinoma
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Grade
Grade I
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Grade
Grade II
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Grade
Grade III
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Grade
Unknown
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
T-stage
T0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
T-stage
Tis
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
T-stage
T1
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
T-stage
T1a
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
T-stage
T1b
|
26 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
T-stage
T1c
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
T-stage
T2
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
ER Status
Positive
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
ER Status
Negative
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ki67 value (%)
|
9.2 percentage of cells
n=5 Participants
|
10.6 percentage of cells
n=7 Participants
|
13.1 percentage of cells
n=5 Participants
|
10.0 percentage of cells
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 yearsPopulation: At 3 years, 131 patients were evaluated for adverse cosmesis.
Participants end up being rated as fair or poor cosmesis from baseline. Excellent: treated breast nearly identical to untreated breast Good: treated breast slightly different than untreated (minimal but identifiable effects of the treated breast) Fair: Treated breast clearly different from untreated but not seriously distorted (significant radiation effects readily observable) Poor: Treated breast seriously distorted (severe sequelae of breast tissue secondary to radiation effects)
Outcome measures
| Measure |
Catheter-based Brachytherapy APBI
n=46 Participants
7 Gy x 3 fractions
\>
\> Brachytherapy APBI
|
3D-CRT APBI
n=47 Participants
7.3 Gy x 3 fractions
* D-CRT (photon) APBI
|
Proton APBI
n=38 Participants
7.3 Gy x 3 fractions \>
\> Proton APBI
|
|---|---|---|---|
|
Change in the Rate of Adverse Cosmesis (Defined as Fair or Poor Cosmesis) Compared to Baseline Using the Harvard Cosmetic Rating:
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Catheter-based Brachytherapy APBI
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
3D-CRT APBI
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Proton APBI
Serious events: 1 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Catheter-based Brachytherapy APBI
n=56 participants at risk
Brachytherapy APBI
|
3D-CRT APBI
n=57 participants at risk
3D-CRT (photon) APBI
|
Proton APBI
n=50 participants at risk
Proton APBI
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
2.0%
1/50 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
Other adverse events
| Measure |
Catheter-based Brachytherapy APBI
n=56 participants at risk
Brachytherapy APBI
|
3D-CRT APBI
n=57 participants at risk
3D-CRT (photon) APBI
|
Proton APBI
n=50 participants at risk
Proton APBI
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
General disorders
Non-cardiac chest pain
|
5.4%
3/56 • Number of events 5 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
10.5%
6/57 • Number of events 7 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
8.0%
4/50 • Number of events 4 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
General disorders
Pain
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
2.0%
1/50 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Infections and infestations
Breast infection
|
1.8%
1/56 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
23.2%
13/56 • Number of events 15 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
31.6%
18/57 • Number of events 18 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
50.0%
25/50 • Number of events 28 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Injury, poisoning and procedural complications
Seroma
|
53.6%
30/56 • Number of events 57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
24.6%
14/57 • Number of events 17 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
34.0%
17/50 • Number of events 22 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Investigations
ECG QT corrected interval prolonged
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
7.1%
4/56 • Number of events 11 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
15.8%
9/57 • Number of events 11 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
6.0%
3/50 • Number of events 4 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Nervous system disorders
Syncope
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
30.4%
17/56 • Number of events 22 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
24.6%
14/57 • Number of events 17 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
32.0%
16/50 • Number of events 19 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.8%
1/56 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Vascular disorders
Hypertension
|
1.8%
1/56 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/57 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Vascular disorders
Hypotension
|
0.00%
0/56 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
1.8%
1/57 • Number of events 1 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
0.00%
0/50 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
|
Vascular disorders
Lymphedema
|
28.6%
16/56 • Number of events 18 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
19.3%
11/57 • Number of events 14 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
12.0%
6/50 • Number of events 8 • Up to 3 years
3 patients were not assessed for AEs after baseline
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place