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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with DCIS | Experimental | Women with DCIS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MammoSite Radiation Therapy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | At 5 Years | |
| Cause Specific Survival | At 5 Years | |
| Disease Free Survival |
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Inclusion Criteria:
Pre-Surgery:
Post-Surgery:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Streeter, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Services | Phoenix | Arizona | 85032 | United States | ||
| Daniel Freeman Hospital |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | Women with DCIS who were willing to enroll and consented |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment to Device Placement-Enrolled |
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|
| At 5 Years |
| Cosmetic Evaluations Over Time | As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint | At 5 Years |
| Inglewood |
| California |
| 90301 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Cedars Medical Center | Miami Beach | Florida | 33136 | United States |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| NY Presbyterian | New York | New York | 10065 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| MD Anderson Cancer Clinic | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Device Placed toTreatment-ITT |
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| Treated Through 5-yr Follow Up-Treated |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated | Subjects enrolled with device placed and treated with partial breast irradiation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of subjects | 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. |
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| Secondary | Overall Survival | Posted | Number | 95% Confidence Interval | participants | At 5 Years |
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| Secondary | Cause Specific Survival | Posted | Number | 95% Confidence Interval | participants | At 5 Years |
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| Secondary | Disease Free Survival | Posted | Number | 95% Confidence Interval | participants | At 5 Years |
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| Secondary | Cosmetic Evaluations Over Time | As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint | Subjects with Cosmetic Evaluation at 5 Years | Posted | Number | percentage of subjects | At 5 Years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intent to Treat | Enrolled subjects with MammoSite device placed | 6 | 118 | 97 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Vascular Accident | Vascular disorders | Systematic Assessment | Subject 09-001 suffered a cerebral vascular accident (CVA) and Subject 09-014 experienced a CVA. Both were determined to be 'Not Related'. |
| |
| Lung cancer with metastases to the brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Subject 09-013 developed lung cancer with metastases to the brain and subsequently died. The event was determined to be 'Not Related'. |
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| Abnormal uterine bleeding | Reproductive system and breast disorders | Systematic Assessment | Subject 01-002 had abnormal uterine bleeding requiring hysterectomy. The event was determined to be 'Not Related'. |
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| Cellulitis | Infections and infestations | Systematic Assessment | Subject 11-011 was admitted to the hospital for evaluation of pain, swelling, fever & chills and was diagnosed with cellulitis & started on IV antibiotics. Event was believed unlikely related & was reported as serious due to hospitalization. |
| |
| Infection | Infections and infestations | Systematic Assessment | One subject in the ITT population experienced an event of infection (Subject 11-014). This event was reported as serious, probably related to the device and after treatment, resolved without sequelae. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Fat Necrosis | General disorders |
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| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fibrosis | General disorders |
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| Induration | General disorders | Systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | Systematic Assessment |
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| Retraction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Radiation Dermatitis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Chenette, Director, Clinical Affairs | Hologic, Inc. | 508-263-8770 | nancy.chenette@hologic.com |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| Positive Margins |
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| Physician Decision |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Other |
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