Breast Cancer
Conditions
Brief summary
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
Interventions
RADIATIONbrachytherapy
breast brachytherapy to 34 Gy
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is \< 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years | 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breast Brachytherapy to 34 Gy breast brachytherapy to a dose of 34 Gy
brachytherapy: breast brachytherapy to 34 Gy | 127 |
| Total | 127 |
Baseline characteristics
| Characteristic | Breast Brachytherapy to 34 Gy |
|---|---|
| Age, Customized Age 30-39 | 2 years |
| Age, Customized Age 40-49 | 29 years |
| Age, Customized Age 50-59 | 35 years |
| Age, Customized Age 60-69 | 45 years |
| Age, Customized Age 70-79 | 14 years |
| Age, Customized Age 80-89 | 2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 124 Participants |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
Time frame: 5 years
Population: No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.
Secondary
To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years
Time frame: 3 years
Population: No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.