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

Mercy Research

Status: Completed

Conditions: Breast Cancer; Ductal Carcinoma in Situ

Treatments: Device: Mammosite ML

Study type: Interventional

Funder types: Other

Identifiers

NCT01448447

Mammosite ML

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women,age of at least 45 years
• Zubrod performance status of 0-2
• AJCC Stage I-II (T1-T2, N0 M0) breast cancer
• Maximum tumor dimension < 3 cm
• Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies
• Unifocal breast cancer
• Unilateral breast cancer (no synchronous or previous contralateral breast cancer)
• Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm
• Ductal Carcinoma In-Situ
• Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with > 6 nodes removed)
• Time interval from final breast surgery to brachytherapy loading less than 8 weeks
• At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer > 5 mm)
• If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.
• Signed study-specific consent form

Exclusion criteria

• Invasive lobular histology
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• Multifocal or multicentric invasive carcinoma
• Extensive intraductal component (EIC)
• Paget's disease of the nipple
• Skin involvement by tumor, regardless of tumor size
• Positive axillary lymph nodes
• Distant metastases
• Collagen vascular disease (scleroderma)
• Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)
• Any previously treated or synchronous contralateral breast carcinoma
• Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent
• Men

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sole method

Experimental group

Description:

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

Treatment:

Device: Mammosite ML

Device: Mammosite ML

Boost

Experimental group

Description:

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

Treatment:

Device: Mammosite ML

Device: Mammosite ML