DCIS
Conditions
Keywords
MammoSite, DCIS
Brief summary
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Detailed description
Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).
Interventions
DEVICEMammoSite Radiation Therapy System
The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
Sponsors
University of Southern California
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-Surgery: * Unicentric pure DCIS * Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI * Post-Surgery: * Negative histological margins confirmed prior to beginning radiation therapy. * Margins are positive if there is tumor at the inked margin. * Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible * Clinically node negative
Exclusion criteria
* Distance from the balloon surface to the surface of the skin \< 5mm as determined by CT imaging. * Distant metastases. * Invasive or in-situ lobular carcinoma (post-surgery assessment). * Nonepithelial breast malignancies such as sarcoma or lymphoma. * DCIS that is multicentric in the ipsilateral breast. * Pregnant or lactating. * Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy. * Collagen vascular diseases * Coexisting medical conditions with life expectancy \< 2 years. * Serious psychiatric or addictive disorder * Previously treated contralateral breast carcinoma * Synchronous bilateral breast carcinoma. * Other malignancy, except non-melanoma skin cancer, \< 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous. * Patients with diffuse disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rate for Follow-up Period of 5 Years. | Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits. | Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | At 5 Years | — |
| Cause Specific Survival | At 5 Years | — |
| Disease Free Survival | At 5 Years | — |
| Cosmetic Evaluations Over Time | At 5 Years | As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint |
Countries
United States
Participant flow
Recruitment details
Per the protocol, a total of 125 subjects were to be enrolled at 10-15 nationwide centers. A total of 133 subjects were enrolled at 12 nationwide centers. Patients with DCIS electing to undergo breast conserving therapy with radiation therapy were screened for enrollment.
Pre-assignment details
Consented patients who were willing to enroll were evaluated prior to surgery. The lumpectomy was performed per the usual standard of care. The MammoSite applicator could be placed at the time of lumpectomy surgery or post-surgery in a separate procedure if adequate evacuated cavity was available as assessed by ultrasound.
Participants by arm
| Arm | Count |
|---|---|
| Treated Subjects enrolled with device placed and treated with partial breast irradiation | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Device Placed toTreatment-ITT | Cavity Conformance | 6 |
| Device Placed toTreatment-ITT | Microinvasion | 1 |
| Device Placed toTreatment-ITT | Physician Decision | 1 |
| Device Placed toTreatment-ITT | Positive Margins | 3 |
| Device Placed toTreatment-ITT | Skin Distance | 7 |
| Enrollment to Device Placement-Enrolled | Cavity Conformance | 4 |
| Enrollment to Device Placement-Enrolled | Microinvasion | 2 |
| Enrollment to Device Placement-Enrolled | Other | 1 |
| Enrollment to Device Placement-Enrolled | Physician Decision | 1 |
| Enrollment to Device Placement-Enrolled | Skin Distance | 6 |
| Enrollment to Device Placement-Enrolled | Withdrawal by Subject | 1 |
| Treated Through 5-yr Follow Up-Treated | Clinical Reason | 1 |
| Treated Through 5-yr Follow Up-Treated | Death | 2 |
| Treated Through 5-yr Follow Up-Treated | Lost to Follow-up | 14 |
| Treated Through 5-yr Follow Up-Treated | Medical Reason | 2 |
| Treated Through 5-yr Follow Up-Treated | Other | 2 |
| Treated Through 5-yr Follow Up-Treated | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Treated |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 31 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants |
| Age Continuous | 61.3 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 100 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 | 97 / 118 |
| serious Total, serious adverse events | 6 / 118 |
Outcome results
Primary
Local Control Rate for Follow-up Period of 5 Years.
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
Time frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Local Control Rate for Follow-up Period of 5 Years. | 99 percentage of subjects |
Secondary
Cause Specific Survival
Time frame: At 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Cause Specific Survival | 100.0 participants |
Secondary
Cosmetic Evaluations Over Time
As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint
Time frame: At 5 Years
Population: Subjects with Cosmetic Evaluation at 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Cosmetic Evaluations Over Time | 42.6 percentage of subjects |
| Good | Cosmetic Evaluations Over Time | 44.7 percentage of subjects |
| Fair | Cosmetic Evaluations Over Time | 12.8 percentage of subjects |
| Poor | Cosmetic Evaluations Over Time | 0.0 percentage of subjects |
Secondary
Disease Free Survival
Time frame: At 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Disease Free Survival | 98.9 participants |
Secondary
Overall Survival
Time frame: At 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Overall Survival | 97.7 participants |