A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
45 Years
N/A
Female
Breast Cancer
Trial Information
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering
partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite®
RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant,
and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device
into the cavity where the tumor was removed either at the time of surgery or percutaneously
under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients
undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive
breast adenocarcinoma
- Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
- Pathologic staging of the axilla preferred
- Clinical staging of the axilla allowed for patients ≥ 70 years of age with
hormone receptor-positive tumors
- Unicentric tumor
- Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
- Must have undergone lumpectomy as definitive surgery
- Negative surgical margins, defined as no tumor at the inked margin of resection
after final surgery
- Re-excision to obtain negative margins allowed
- Must have adequate skin spacing between balloon surface and surface of the skin and
lung (≥ 7 mm)
- No multicentric carcinoma (invasive or DCIS) in more than one quadrant
- No clinically or pathologically positive regional lymph nodes
- No extensive intraductal component, defined as DCIS extending beyond the primary
invasive component into normal breast parenchyma and composing > 25% of the primary
tumor
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No collagen-vascular disease, including any of the following:
- Dermatomyositis
- Systemic lupus erythematosus
- Scleroderma-mixed connective tissue disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Proportion of local recurrence at 5 years
Safety Issue:
No
Principal Investigator
Edward Kim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000651359
NCT ID:
NCT01008514
Start Date:
August 2009
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- stage IA breast cancer
- stage IB breast cancer
- stage II breast cancer
- Breast Neoplasms
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