Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.

Detailed Description
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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.

Official Title
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A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: adjuvant therapy
* Radiation: accelerated partial breast irradiation
* Radiation: intracavitary balloon brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|nan|
|Radiation: accelerated partial breast irradiation|nan|
|Radiation: intracavitary balloon brachytherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of local recurrence | Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toxicity |  | up to 30 months after radiotherapy | 
| Cosmetic results |  | up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer