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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
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.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Time frame: 1 year after treatment
Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Time frame: 5 years after treatment
Percentage of Patients Who Experienced Complications
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.
Time frame: within 6 months of treatment
Percentage of Patients Who Experienced Complications
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.
Time frame: more than 6 months after treatment, for up to 5 years
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
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.
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Time frame: 6 months after treatment
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
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.
Time frame: 12 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
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.
Time frame: 6 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
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.
Time frame: 12 months after treatment