A Phase 1 interventional study of Radiosurgery in Breast Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Duke University · Phase 1, Interventional, and Treatment
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.
This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.
Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Also known as: External beam radiation therapy
Maximum Tolerated Dose
As measured by the incidence of acute toxicity and wound healing complications
Time frame: 30 days
Cosmetic Outcome
Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size.
Time frame: 3 years
Local Control
Time frame: 3 years
Acquire Tissue
Pre and post-radiotherapy for exploratory analysis of radiation response
Time frame: Pre and post SRS radiosurgery
Magnetic Resonance Images(MRI)
Pre and post-radiotherapy for exploratory analysis of radiation response.
Time frame: Pre and post SRS radiosurgery
| Milestone | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 |
|---|---|---|---|
| Started | 9 | 10 | 16 |
| Completed | 8 | 8 | 16 |
| Not completed | 1 | 2 | 0 |
As measured by the incidence of acute toxicity and wound healing complications
| Gray (Gy) | Single Dose Radiosurgery: All Dose Levels |
|---|---|
| Maximum Tolerated Dose | 21 |
Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size.
| percentage of participants | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 |
|---|---|---|---|
| Cosmetic Outcome | 71 | 100 | 100 |
No measurements were reported for this outcome.
Pre and post-radiotherapy for exploratory analysis of radiation response
Results for this outcome have not been posted.
Pre and post-radiotherapy for exploratory analysis of radiation response.
Results for this outcome have not been posted.
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Dose Radiosurgery: Dose Level 1 | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Single Dose Radiosurgery: Dose Level 2 | 1/8 (12.5%) | 0/8 (0%) | 8/8 (100%) |
| Single Dose Radiosurgery: Dose Level 3 | 1/16 (6.3%) | 0/16 (0%) | 15/16 (93.8%) |
| Event | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 |
|---|---|---|---|
| Fibrosis deep connective tissueMusculoskeletal and connective tissue disorders | 7/8 | 7/8 | 13/16 |
| Breast painReproductive system and breast disorders | 4/8 | 5/8 | 8/16 |
| Dermatitis radiationInjury, poisoning and procedural complications | 2/8 | 4/8 | 9/16 |
| SeromaInjury, poisoning and procedural complications | 0/8 | 4/8 | 8/16 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 2/8 | 3/8 | 4/16 |
| Skin indurationSkin and subcutaneous tissue disorders | 3/8 | 1/8 | 5/16 |
| FatigueGeneral disorders | 0/8 | 2/8 | 2/16 |
| Breast infectionInfections and infestations | 0/8 | 2/8 | 0/16 |
| Breast atrophyReproductive system and breast disorders | 2/8 | 1/8 | 3/16 |
| Reproductive system and breast disorders-OtherReproductive system and breast disorders | 2/8 | 2/8 | 0/16 |
Participants who completed the study.
| Age, Continuous(years) | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 | Total |
|---|---|---|---|---|
| Mean | 65.3 ± 7.0 | 65.3 ± 7.1 | 67.2 ± 7.1 | 66.2 ± 6.9 |
| Sex: Female, Male(Participants) | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 | Total |
|---|---|---|---|---|
| Female | 8 | 8 | 16 | 32 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 8 | 15 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 |
| White | 8 | 7 | 15 | 30 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 | Single Dose Radiosurgery: Dose Level 3 | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 16 | 32 |
Ran from Jul 2010 to primary completion in Apr 2016, 68 months.
Results were first posted in Feb 2020, 3 years 10 months after primary completion.
Of 339 non-industry phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 77. This study's 68 months is above that.
Counting every sponsor, half of 645 studies reached it within 45 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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