Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ breast cancer in situ
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief summary:
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

Detailed description:
OBJECTIVES:

Primary

* Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite\^® Radiation Therapy System.

Secondary

* Determine the early and late complication rates and cosmetic outcome in these patients after treatment.

OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins\* (no ink on tumor) undergo placement of the MammoSite\^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.

NOTE: \*If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.

Beginning 2-5 days after placement of the MammoSite\^®, patients undergo brachytherapy through the MammoSite\^® twice daily for 5 days (a total of 10 fractions).

After completion of study treatment, patients are followed periodically for ≥ 5 years.

Arms:
arm 1: Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.

Interventions: intervention 1: Tamoxifen intervention 2: Lumpectomy intervention 3: brachytherapy
Intervention descriptions: intervention 1: Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient intervention 2: A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS. intervention 3: Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.

Protocol document: