Clinical trial NCT01448447: Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ipsilateral Recurrence Rate
timeFrame: 5 years
Secondary outcomes:
measure: Cosmetic Results
timeFrame: 6 months after treatment, then annually for 5 years
measure: Toxicity Measured Through Adverse Event Incidence
timeFrame: during therapy, 6 weeks after completion of therapy, and additionally as needed
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Clinic St. Louis Cancer and Breast Institute
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
Study officials:
affiliation: Mercy Hospital St. Louis
name: Bethany G Sleckman, MD
role: PRINCIPAL_INVESTIGATOR
References: