Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

Phase 2

Terminated

Interventions: Drug: Tamoxifen
Procedure: Lumpectomy
Radiation: brachytherapy

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.

Recruitment & Eligibility

Inclusion Criteria

Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
Size: < 3 cm on mammogram
Unicentric disease
Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
Patient Age: ≥ 18 years, no upper limit
Life expectancy > 5 years

Exclusion Criteria

Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
Pregnant or breast feeding
Multicentric disease
Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis

Arm && Interventions

Group	Intervention	Description
Lumpectomy with Brachytherapy	brachytherapy	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.
Lumpectomy with Brachytherapy	Lumpectomy	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.
Lumpectomy with Brachytherapy	Tamoxifen	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Ipsilateral Breast Tumor Recurrence	5 years after treatment	Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Experienced Complications	more than 6 months after treatment, for up to 5 years	Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent	12 months after treatment	The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent	12 months after treatment	The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.