Breast Cancer
Conditions
Keywords
Cancer of Breast, Cancer of the Breast, Neoplasms, Breast, Single dose radiation, Radiotherapy, Preoperative
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONRadiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast * Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery) * Clinical T1N0M0 * 55 years of age or older * Estrogen receptor (ER) positive, * No evidence of lymphovascular space invasion on initial biopsy * Not pregnant. If not post-menopausal must adhere to birth control measures * White blood cell count \> 3000, Hemoglobin \> 9, platelets \>100000 * Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min
Exclusion criteria
* Neoadjuvant chemotherapy * Breast implants * Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma) * Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length * HER-2/neu positive * Positive serum pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | 30 days | As measured by the incidence of acute toxicity and wound healing complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome | 3 years | 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. |
| Local Control | 3 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acquire Tissue | Pre and post SRS radiosurgery | Pre and post-radiotherapy for exploratory analysis of radiation response |
| Magnetic Resonance Images(MRI) | Pre and post SRS radiosurgery | Pre and post-radiotherapy for exploratory analysis of radiation response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Dose Radiosurgery: Dose Level 1 A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy | 8 |
| Single Dose Radiosurgery: Dose Level 2 A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy | 8 |
| Single Dose Radiosurgery: Dose Level 3 A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Single Dose Radiosurgery: Dose Level 3 | Total | Single Dose Radiosurgery: Dose Level 1 | Single Dose Radiosurgery: Dose Level 2 |
|---|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7.1 | 66.2 years STANDARD_DEVIATION 6.9 | 65.3 years STANDARD_DEVIATION 7 | 65.3 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 30 Participants | 8 Participants | 7 Participants |
| Region of Enrollment United States | 16 Participants | 32 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 16 Participants | 32 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 1 / 8 | 1 / 16 |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 15 / 16 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 16 |
Outcome results
Primary
Maximum Tolerated Dose
As measured by the incidence of acute toxicity and wound healing complications
Time frame: 30 days
Population: Participants receiving all dose levels (8 at 15Gy/Dose level 1, 8 at 18Gy/Dose level 2, 16 at 21Gy/Dose level 3)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Dose Radiosurgery: All Dose Levels | Maximum Tolerated Dose | 21 Gray (Gy) |
Secondary
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
Population: Participants with a physician's assessment available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Dose Radiosurgery: All Dose Levels | Cosmetic Outcome | 71 percentage of participants |
| Single Dose Radiosurgery: Dose Level 2 | Cosmetic Outcome | 100 percentage of participants |
| Single Dose Radiosurgery: Dose Level 3 | Cosmetic Outcome | 100 percentage of participants |
Secondary
Local Control
Time frame: 3 years
Population: Data not collected.
Other Pre-specified
Acquire Tissue
Pre and post-radiotherapy for exploratory analysis of radiation response
Time frame: Pre and post SRS radiosurgery
Other Pre-specified
Magnetic Resonance Images(MRI)
Pre and post-radiotherapy for exploratory analysis of radiation response.
Time frame: Pre and post SRS radiosurgery