Breast Cancer
Conditions
Keywords
ductal breast carcinoma in situ, breast cancer in situ
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.
Interventions
DRUGTamoxifen
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
PROCEDURELumpectomy
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
RADIATIONbrachytherapy
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.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Ipsilateral Breast Tumor Recurrence | 1 year 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Experienced Complications | within 6 months of treatment | 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 | 6 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 | 6 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. |
Countries
United States
Participant flow
Recruitment details
Eligible patients wereinvited to participate in the study by their physician, who explained the details of the trial and obtained informed consent. Patients who met the eligibility criteria and signed the appropriate consent were entered into the study before the MammoSite device was inserted.
Pre-assignment details
A total of 45 subjects were enrolled. Four subjects did not receive accelerated partial breast irradiation because the minimum distance from the skin to the internal radiation device was \<5mm and is associated with poor cosmetic results.
Participants by arm
| Arm | Count |
|---|---|
| MammoSite Treatment Group 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. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | MammoSite Treatment Group |
|---|---|
| Age, Continuous | 54 years |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 41 |
| serious Total, serious adverse events | 1 / 41 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Number of Patients With Ipsilateral Breast Tumor Recurrence | 0 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Number of Patients With Ipsilateral Breast Tumor Recurrence | 4 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 92.3 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 96.8 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Patients Who Experienced Complications | 65.8 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Patients Who Experienced Complications | 24.4 percentage of participants |
Secondary
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: 6 months after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 100 percentage of physicians |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Patients | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 86.7 percentage of physicians |