Trial Outcomes & Findings for Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer (NCT NCT00694577)
NCT ID: NCT00694577
Last Updated: 2022-11-14
Results Overview
Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
324 participants
Primary outcome timeframe
10 years
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Irradiation Using 32 Gy / 8 Fractions
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Irradiation Using 36 Gy / 9 Fractions
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Irradiation Using 40 Gy / 10 Fractions
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
124
|
|
Overall Study
COMPLETED
|
98
|
101
|
124
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=98 Participants
Study Participants 1-100
Partial Breast Irradiation using 32 Gy / 8 fractions, BID: 4 Treatment Days, within 1 week
|
Group 2
n=101 Participants
Study Participants 101-200
Partial Breast Irradiation using 36 Gy / 9 fractions, BID: 4 1/2 Treatment Days, within 1 week
|
Group 3
n=124 Participants
Study Participants 201-330
Partial Breast Irradiation using 40 Gy / 10 fractions, BID: 5 Treatment Days, within 1 week
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=98 Participants
|
61 years
n=101 Participants
|
60 years
n=124 Participants
|
61 years
n=323 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=98 Participants
|
101 Participants
n=101 Participants
|
124 Participants
n=124 Participants
|
323 Participants
n=323 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=98 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=323 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
98 participants
n=98 Participants
|
101 participants
n=101 Participants
|
124 participants
n=124 Participants
|
323 participants
n=323 Participants
|
|
Number of patients with triple negative cancer (ER-/PR-/HER2-)
|
10 Participants
n=98 Participants
|
4 Participants
n=101 Participants
|
2 Participants
n=124 Participants
|
16 Participants
n=323 Participants
|
PRIMARY outcome
Timeframe: 10 yearsFeasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
|
98 Participants
|
101 Participants
|
124 Participants
|
PRIMARY outcome
Timeframe: 10 yearsRisk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
|
6 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 yearsNumber of patients who presented with moderate to severe composite toxicity as an endpoint
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint
|
46 Participants
|
67 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: 8 yearsRate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation
|
37 Participants
|
52 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 8 yearsNumber of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes.
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation
|
21 Participants
|
36 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 8 yearsA survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance.
Outcome measures
| Measure |
Group 1
n=98 Participants
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 2
n=101 Participants
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
Group 3
n=124 Participants
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days
|
|---|---|---|---|
|
To Evaluate Patient Satisfaction
|
94 Participants
|
94 Participants
|
110 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place