Breast Cancer
Conditions
Keywords
breast, cancer, breast cancer, prone, partial breast irradiation, PBI
Brief summary
The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
Detailed description
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected. All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days
Interventions
RADIATIONPBI Radiotherapy 6 Gy
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
RADIATIONPBI Radiotherapy 8 Gy
Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Post-menopausal women defined as either: 1. at least 2 years without menstrual period 2. patients older than 50 with serological evidence of post-menopausal status 3. hysterectomized patients of any age with FSH confirmation of post- menopausal status * pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis: 1. Screen-detected 2. Low to intermediate nuclear grade 3. \< 2.5cm in size 4. Resected with negative margins at \>3mm) * clinically N0 or pN0 or sentinel node negative breast cancer
Exclusion criteria
* previous radiation therapy to the ipsilateral breast * presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Grade 2 or 3 Fibrosis | 60 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Isolated Local/Regional Recurrences | 1 year post randomization |
| Rate of Concomitant Local/Regional and Distant Recurrences | 1 year post randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PBI Radiotherapy 6 Gy Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
PBI Radiotherapy 6 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days | 144 |
| PBI Radiotherapy 8 Gy Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
PBI Radiotherapy 8 Gy: Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day | 140 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | PBI Radiotherapy 6 Gy | Total | PBI Radiotherapy 8 Gy |
|---|---|---|---|
| Age, Continuous | 69 years | 68 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 22 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 246 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 13 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 33 Participants | 18 Participants |
| Race (NIH/OMB) White | 110 Participants | 219 Participants | 109 Participants |
| Region of Enrollment United States | 144 participants | 284 participants | 140 participants |
| Sex: Female, Male Female | 144 Participants | 284 Participants | 140 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 144 | 4 / 140 |
| other Total, other adverse events | 144 / 144 | 140 / 140 |
| serious Total, serious adverse events | 0 / 144 | 1 / 140 |
Outcome results
Primary
Percentage of Participants With Grade 2 or 3 Fibrosis
Time frame: 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PBI Radiotherapy 6 Gy | Percentage of Participants With Grade 2 or 3 Fibrosis | 18.30 percentage of participants |
| PBI Radiotherapy 8 Gy | Percentage of Participants With Grade 2 or 3 Fibrosis | 12.30 percentage of participants |
Secondary
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 3 years post randomization
Secondary
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 2 years post randomization
Secondary
Rate of Concomitant Local/Regional and Distant Recurrences
Time frame: 1 year post randomization
Secondary
Rate of Isolated Local/Regional Recurrences
Time frame: 3 years post randomization
Secondary
Rate of Isolated Local/Regional Recurrences
Time frame: 1 year post randomization
Secondary
Rate of Isolated Local/Regional Recurrences
Time frame: 2 years post randomization