A Phase 2 interventional study of Tamoxifen and Lumpectomy in Breast Cancer, sponsored by Masonic Cancer Center, University of Minnesota. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-28.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment
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
Secondary
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 45 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: Lumpectomy · Radiation: brachytherapy
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.
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.
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
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.
| Milestone | MammoSite Treatment Group |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
| participants | Evaluable Patients |
|---|---|
| Number of Patients With Ipsilateral Breast Tumor Recurrence | 0 |
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
| participants | Evaluable Patients |
|---|---|
| Number of Patients With Ipsilateral Breast Tumor Recurrence | 4 |
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 participants | Evaluable Patients |
|---|---|
| Percentage of Patients Who Experienced Complications | 65.8 |
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 participants | Evaluable Patients |
|---|---|
| Percentage of Patients Who Experienced Complications | 24.4 |
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 physicians | Evaluable Patients |
|---|---|
| Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 100 |
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 physicians | Evaluable Patients |
|---|---|
| Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 86.7 |
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 participants | Evaluable Patients |
|---|---|
| Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 96.8 |
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 participants | Evaluable Patients |
|---|---|
| Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 92.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MammoSite Treatment Group | — | 1/41 (2.4%) | 28/41 (68.3%) |
| Event | MammoSite Treatment Group |
|---|---|
| Skin ulcerationSkin and subcutaneous tissue disorders | 1/41 |
| Event | MammoSite Treatment Group |
|---|---|
| Breast tenderness/pain - early onsetInjury, poisoning and procedural complications | 11/41 |
| Erythema - early onsetInjury, poisoning and procedural complications | 11/41 |
| Pigmentation - early onsetSkin and subcutaneous tissue disorders | 8/41 |
| Induration - early onsetSkin and subcutaneous tissue disorders | 6/41 |
| Hematoma/seroma - early onsetInjury, poisoning and procedural complications | 5/41 |
| Breast tenderness/pain - late onsetInjury, poisoning and procedural complications | 4/41 |
| Infection - early onsetInfections and infestations | 4/41 |
| Telangiectasia - late onsetSkin and subcutaneous tissue disorders | 4/41 |
| Age, Continuous(years) | MammoSite Treatment Group |
|---|---|
| Median | 54 (36 to 86) |
| Sex: Female, Male(Participants) | MammoSite Treatment Group |
|---|---|
| Female | 41 |
| Male | 0 |
| Region of Enrollment(participants) | MammoSite Treatment Group |
|---|---|
| United States | 41 |
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota