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This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sole method | Experimental | patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS |
|
| Boost | Experimental | patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mammosite ML | Device | 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral Recurrence Rate |
Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Results | Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany G Sleckman, MD | Mercy Hospital St. Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Clinic St. Louis Cancer and Breast Institute | St Louis | Missouri | 63011 | United States | ||
| Mercy Hospital St. Louis |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sole Method | patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days |
| FG001 | Boost | patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
20 patients were enrolled within sole method arm, no patients were enrolled in boost method arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Sole Method | patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Ipsilateral Recurrence Rate |
Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0 | 11 patients within sole method arm were lost to follow-up prior to 5 year follow-up period. | Posted | Number | participants | 5 years |
|
Adverse events will be collected during follow-up visits non-systematically over the course of 5 years beginning from procedure.
Adverse event information not collected from boost method arm patients, as there were no patients enrolled for the boost method arm.
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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 | Sole Method | patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Frazier | Mercy | 314-251-6844 | Robert.Frazier@mercy.net |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Mammosite ML | Device | 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) |
|
|
| 6 months after treatment, then annually for 5 years |
| Toxicity Measured Through Adverse Event Incidence | The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures. | during therapy, 6 weeks after completion of therapy, and additionally as needed |
| St Louis |
| Missouri |
| 63141 |
| United States |
| Boost |
patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Boost | patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) |
|
|
| Secondary | Cosmetic Results | Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation | No patient information was collected for boost method arm as no patients were enrolled into boost method arm. 11 participants in sole method arm were lost to follow-up over 5 year period. | Posted | Count of Participants | Participants | 6 months after treatment, then annually for 5 years |
|
|
|
| Secondary | Toxicity Measured Through Adverse Event Incidence | The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures. | No patient information was collected for boost method arm as no patients were enrolled into boost method arm of study. | Posted | Count of Participants | Participants | during therapy, 6 weeks after completion of therapy, and additionally as needed |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Boost | patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| Number of pts with "fair" cosmetic results, 1 year post treatment |
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| Number of pts with "poor" cosmetic results, 1 year post treatment |
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| Number of pts with "excellent" cosmetic results, 2 years post treatment |
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| Number of pts with "good" cosmetic results, 2 years post treatment |
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| Number of pts with "fair" cosmetic results, 2 years post treatment |
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| Number of pts with "poor" cosmetic results, 2 years post treatment |
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| Number of pts with "excellent" cosmetic results, 3 years post treatment |
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| Number of pts with "good" cosmetic results, 3 years post treatment |
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| Number of pts with "fair" cosmetic results, 3 years post treatment |
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| Number of pts with "poor" cosmetic results, 3 years post treatment |
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| Number of pts with "excellent" cosmetic results, 4 years post treatment |
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| Number of pts with "good" cosmetic results, 4 years post treatment |
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| Number of pts with "fair" cosmetic results, 4 years post treatment |
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| Number of pts with "poor" cosmetic results, 4 years post treatment |
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| Number of pts with "excellent" cosmetic results, 5 years post treatment |
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| Number of pts with "good" cosmetic results, 5 years post treatment |
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| Number of pts with "fair" cosmetic results, 5 years post treatment |
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| Number of pts with "poor" cosmetic results, 5 years post treatment |
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