A Phase 2 interventional study of brachytherapy in Breast Cancer, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 127 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
breast brachytherapy to a dose of 34 Gy
Radiation: brachytherapy
breast brachytherapy to 34 Gy
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
To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years
Time frame: 3 years
| Milestone | Breast Brachytherapy to 34 Gy |
|---|---|
| Started | 127 |
| Completed | 0 |
| Not completed | 127 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over The study was terminated early, adverse events data were collected on paper that presumably are with the PI.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Brachytherapy to 34 Gy | — | — | — |
| Age, Customized(years) | Breast Brachytherapy to 34 Gy |
|---|---|
| Age 30-39 | 2 |
| Age 40-49 | 29 |
| Age 50-59 | 35 |
| Age 60-69 | 45 |
| Age 70-79 | 14 |
| Age 80-89 | 2 |
| Sex: Female, Male(Participants) | Breast Brachytherapy to 34 Gy |
|---|---|
| Female | 127 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Breast Brachytherapy to 34 Gy |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 123 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Breast Brachytherapy to 34 Gy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 124 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Breast Brachytherapy to 34 Gy |
|---|---|
| United States | 127 |
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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