Status:
COMPLETED
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
Lead Sponsor:
Mercy Research
Conditions:
Breast Cancer
Ductal Carcinoma in Situ
Eligibility:
FEMALE
45+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01448447
Start Date
December 1 2009
End Date
April 1 2016
Last Update
July 15 2021
Active Locations (2)
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1
Mercy Clinic St. Louis Cancer and Breast Institute
St Louis, Missouri, United States, 63011
2
Mercy Hospital St. Louis
St Louis, Missouri, United States, 63141