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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Ductal Carcinoma in Situ	Device: Mammosite ML	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Cosmetics

U.S. FDA Resources

Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:

ipsilateral recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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.

Secondary Outcome Measures:

cosmetic results [ Time Frame: 6 months after treatment, then annually for 5 years ] [ Designated as safety issue: No ]
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
toxicity [ Time Frame: during therapy, 6 weeks after completion of therapy, and additionally as needed ] [ Designated as safety issue: Yes ]
The incidence of serious adverse events will be calculated.

Estimated Enrollment:	200
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Device: 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 Other Name: HDR Brachytherapy
Experimental: 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	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) Other Name: HDR Brachytherapy

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448447

Contacts

Contact: Kathy Baglan, MD		kathy.baglan@mercy.net
Contact: Julie Mai, MD		julie.mai@mercy.net

Locations

United States, Missouri
Mercy Hospital St. Louis	Recruiting
St. Louis, Missouri, United States, 63141
Mercy Clinic St. Louis Cancer and Breast Institute	Recruiting
St. Louis, Missouri, United States, 63011

Sponsors and Collaborators

St. John's Mercy Research Institute, St. Louis

Investigators

Principal Investigator:

Bethany G Sleckman, MD

Mercy Hospital St. Louis

More Information

No publications provided

Responsible Party:	Bethany Sleckman, Director of Oncology Research, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:	NCT01448447 History of Changes
Other Study ID Numbers:	Mammosite ML
Study First Received:	September 30, 2011
Last Updated:	December 12, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site

Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 23, 2013

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