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

Ohio State University Comprehensive Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Breast Cancer

Interventions

adjuvant therapyPROCEDURE

accelerated partial breast irradiationRADIATION

intracavitary balloon brachytherapyRADIATION

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 5 years

Secondary Outcomes

Safety and toxicity

Time frame: up to 30 months after radiotherapy

Cosmetic results

Time frame: up to 30 months

Data from ClinicalTrials.gov

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