Clinical trial NCT01008514: Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
Official title: A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of local recurrence
timeFrame: up to 5 years
Secondary outcomes:
measure: Safety and toxicity
timeFrame: up to 30 months after radiotherapy
measure: Cosmetic results
timeFrame: up to 30 months
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Edward Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: