Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Breast Carcinoma In Situ

patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS

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

34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days

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)

Bethany G Sleckman, MD

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:

* For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates.
* Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy.
* Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast

* Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume.
* Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume.
* Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable.

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

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

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.

Mercy Research

MD, Radiation Oncologist

Adverse event information not collected from boost method arm patients, as there were no patients enrolled for the boost method arm.

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

Sole Method

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)

Boost

Total

Age, Categorical

Sex: Female, Male

20 patients were enrolled within sole method arm, no patients were enrolled in boost method arm

Dr. Robert Frazier

11 patients within sole method arm were lost to follow-up prior to 5 year follow-up period.

Ipsilateral Recurrence Rate

Number of pts with "excellent" cosmetic results, 1 year post treatment

Number of pts with "good" cosmetic results, 1 year post treatment

Number of pts with "fair" cosmetic results, 1 year post treatment

Number of pts with "poor" cosmetic results, 1 year post treatment

Number of pts with "excellent" cosmetic results, 2 years post treatment

Number of pts with "good" cosmetic results, 2 years post treatment

Number of pts with "fair" cosmetic results, 2 years post treatment

Number of pts with "poor" cosmetic results, 2 years post treatment

Number of pts with "excellent" cosmetic results, 3 years post treatment

Number of pts with "good" cosmetic results, 3 years post treatment

Number of pts with "fair" cosmetic results, 3 years post treatment

Number of pts with "poor" cosmetic results, 3 years post treatment

Number of pts with "excellent" cosmetic results, 4 years post treatment

Number of pts with "good" cosmetic results, 4 years post treatment

Number of pts with "fair" cosmetic results, 4 years post treatment

Number of pts with "poor" cosmetic results, 4 years post treatment

Number of pts with "excellent" cosmetic results, 5 years post treatment

Number of pts with "good" cosmetic results, 5 years post treatment

Number of pts with "fair" cosmetic results, 5 years post treatment

Number of pts with "poor" cosmetic results, 5 years post treatment

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.

Cosmetic Results

No patient information was collected for boost method arm as no patients were enrolled into boost method arm of study.

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