Trial Outcomes & Findings for Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer (NCT NCT01463007)
NCT ID: NCT01463007
Last Updated: 2021-05-19
Results Overview
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
2 years
Results posted on
2021-05-19
Participant Flow
40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.
Participant milestones
| Measure |
Radiation
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Radiation
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Radiation
n=41 Participants
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
61.46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAny toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
Outcome measures
| Measure |
Radiation
n=41 Participants
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
Extended to 5 Years of Follow Up-Rhode Island Hospital Only
n=28 Participants
Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
|
|---|---|---|
|
Early and Intermediate Toxicity
|
40 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 2 yearsCosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.
Outcome measures
| Measure |
Radiation
n=41 Participants
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
Extended to 5 Years of Follow Up-Rhode Island Hospital Only
Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
|
|---|---|---|
|
Cosmetic Outcome
|
35 participants
|
—
|
Adverse Events
Radiation
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation
n=41 participants at risk
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
|---|---|
|
Investigations
Infection
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Creatinine
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Hypokalemia
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Bicarbonate
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
SGOT
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Alkaline Phosphatase value
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Hyperbilirubineamia
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Hypoalbuminemia
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Leukocytes
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Hemoglobin
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Neutrophils
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
INR
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
PTT
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Fibrinogen
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
Other adverse events
| Measure |
Radiation
n=41 participants at risk
AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
|
|---|---|
|
Investigations
Discomfort
|
85.4%
35/41 • Number of events 35 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
acute skin rxn
|
78.0%
32/41 • Number of events 32 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
skin induration/fibrosis
|
26.8%
11/41 • Number of events 11 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
hyperpigmentation
|
53.7%
22/41 • Number of events 22 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
fatigue
|
43.9%
18/41 • Number of events 18 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
breast volume
|
26.8%
11/41 • Number of events 11 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
seroma
|
4.9%
2/41 • Number of events 2 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
fat necrosis
|
4.9%
2/41 • Number of events 2 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Itching
|
0.00%
0/41 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Fibrosis Cosmesis
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Talangiectasis
|
19.5%
8/41 • Number of events 8 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
breast pain
|
17.1%
7/41 • Number of events 7 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Nausea
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
Diarrhea
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
|
Investigations
erythema
|
2.4%
1/41 • Number of events 1 • Data was collected from signing of ICF until 2 years post treatment.
|
Additional Information
Dr. Jaroslaw Hepel
BrUOG-Brown University Oncology Research Group
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place