Breast Cancer
Conditions
Keywords
Stage I, Stage II, Breast, Cancer
Brief summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Detailed description
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
Interventions
RADIATIONElectronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Sponsors
Xoft, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 years * Tumor with Tis, T1, N0, M0 - (AJC Classification) * Invasive ductal carcinoma or ductal carcinoma in situ * Negative microscopic surgical margins of at least 1mm in all directions * Adequate skin spacing between balloon surface and surface of the skin - (\> 7mm)
Exclusion criteria
* Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention) * Scleroderma, systemic sclerosis and active lupus * Infiltrating lobular histology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Delivery of 34 Gy in 10 Fractions | measured at end of 10th fraction, usually within 7 days | Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | Through 6 months | Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported. |
Countries
United States
Participant flow
Recruitment details
Hospitals with radiation oncology departments who had acquired the Xoft Axxent system and were qualified to be in the study were chosen as the 10 sites. Breast surgeons and radiation oncologists were the site investigators at 10 sites.
Pre-assignment details
This was a single arm study, no randomization. Some patients consented but fell out of the study due to not meeting all eligibility (I/E) criteria after consenting to participation. 61 patients provided consent, 44 were treated.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Brachytherapy Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 5 Year Follow-up | Lost to Follow-up | 9 |
| 5 Year Follow-up | Mastectomy | 3 |
| Eligibility Through 6 Month Follow-up | Lost to Follow-up | 1 |
| One-year Follow-up | Lost to Follow-up | 2 |
| One-year Follow-up | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Electronic Brachytherapy |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 8.24 |
| Age, Customized <=18 years | 0 participants |
| Age, Customized >=50 years | 42 participants |
| Age, Customized Between 18 and 50 years | 2 participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Number of Participants With Delivery of 34 Gy in 10 Fractions
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
Time frame: measured at end of 10th fraction, usually within 7 days
Population: All patients treated were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Brachytherapy | Number of Participants With Delivery of 34 Gy in 10 Fractions | 42 Participants |
Secondary
Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.
Time frame: Through 6 months
Population: All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Brachytherapy | Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | 0 events |