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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen
* Procedure: Lumpectomy
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumpectomy with Brachytherapy<br>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. | Drug: Tamoxifen<br>* Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient<br>Procedure: Lumpectomy<br>* A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.<br>Radiation: brachytherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, breast cancer in situ