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

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ClinicalTrials.gov Identifier: NCT00290654
Recruitment Status : Terminated (Unable to recruit further patients.)
First Posted : February 13, 2006
Results First Posted : May 15, 2015
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Tamoxifen
Procedure: Lumpectomy
Radiation: brachytherapy
Enrollment 45
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.
Arm/Group Title MammoSite Treatment Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title MammoSite Treatment Group
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
54
(36 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Number of Patients With Ipsilateral Breast Tumor Recurrence
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Number of Patients With Ipsilateral Breast Tumor Recurrence
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
4
3.Secondary Outcome
Title Percentage of Patients Who Experienced Complications
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
65.8
4.Secondary Outcome
Title Percentage of Patients Who Experienced Complications
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
24.4
5.Secondary Outcome
Title Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of physicians
100
6.Secondary Outcome
Title Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of physicians
86.7
7.Secondary Outcome
Title Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
96.8
8.Secondary Outcome
Title Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
92.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MammoSite Treatment Group
Hide Arm/Group Description 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.
All-Cause Mortality
MammoSite Treatment Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MammoSite Treatment Group
Affected / at Risk (%)
Total   1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
Skin ulceration   1/41 (2.44%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MammoSite Treatment Group
Affected / at Risk (%)
Total   28/41 (68.29%) 
Infections and infestations   
Infection - early onset  4/41 (9.76%) 
Injury, poisoning and procedural complications   
Breast tenderness/pain - early onset  11/41 (26.83%) 
Breast tenderness/pain - late onset  4/41 (9.76%) 
Erythema - early onset  11/41 (26.83%) 
Hematoma/seroma - early onset  5/41 (12.20%) 
Skin and subcutaneous tissue disorders   
Pigmentation - early onset  8/41 (19.51%) 
Telangiectasia - late onset  4/41 (9.76%) 
Induration - early onset  6/41 (14.63%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Todd Tuttle, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-625-2991
EMail: tuttl005@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00290654     History of Changes
Other Study ID Numbers: 2002LS097
UMN-0211M35761 ( Other Identifier: IRB, University of Minnesota )
First Submitted: February 9, 2006
First Posted: February 13, 2006
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: December 28, 2017