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

NCT ID: NCT01448447

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mammosite ML

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Mammosite ML

Intervention Type: 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)

Interventions

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

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

Other Intervention Names

HDR Brachytherapy; HDR Brachytherapy

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Robert Frazier, MD

MD, Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bethany G Sleckman, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital St. Louis

Locations

Mercy Clinic St. Louis Cancer and Breast Institute

St Louis, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

Mammosite ML

Identifier Type: -

Identifier Source: org_study_id