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

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00290654
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 123
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Tamoxifen; Procedure: Lumpectomy; Radiation: brachytherapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Lumpectomy with Brachytherapy 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; Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient; Procedure: Lumpectomy; A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.; Radiation: brachytherapy; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Number of Patients With Ipsilateral Breast Tumor Recurrence [5 years 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 Outcome Measures

1. 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.

2. Percentage of Patients Who Experienced Complications [more than 6 months after treatment, for up to 5 years]

   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.

3. 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.

4. Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent [12 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.

5. 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.

6. Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent [12 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota

Investigators

• Principal Investigator: Todd M. Tuttle, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00290654
• Other Study ID Numbers: 2002LS097; UMN-0211M35761
• First Posted: Feb 13, 2006
• Last Update Posted: Dec 28, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Masonic Cancer Center, University of Minnesota: ductal breast carcinoma in situ; breast cancer in situ
• Additional relevant MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Tamoxifen

Study Results

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	MammoSite Treatment Group
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 Participants	41
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	41 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Ipsilateral Breast Tumor Recurrence
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [participants]	0 0%

2. Primary Outcome

Title	Number of Patients With Ipsilateral Breast Tumor Recurrence
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [participants]	4 9.8%

3. Secondary Outcome

Title	Percentage of Patients Who Experienced Complications
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of participants]	65.8 160.5%

4. Secondary Outcome

Title	Percentage of Patients Who Experienced Complications
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of participants]	24.4 59.5%

5. Secondary Outcome

Title	Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of physicians]	100

6. Secondary Outcome

Title	Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of physicians]	86.7

7. Secondary Outcome

Title	Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of participants]	96.8 236.1%

8. Secondary Outcome

Title	Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluable Patients
Arm/Group Description	Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Measure Participants	41
Number [percentage of participants]	92.3 225.1%

Adverse Events

Arm/Group Title	MammoSite Treatment Group
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	MammoSite Treatment Group
	Affected / at Risk (%)	# Events
Total	1/41 (2.4%)
Skin and subcutaneous tissue disorders
Skin ulceration	1/41 (2.4%)
Other (Not Including Serious) Adverse Events
	MammoSite Treatment Group
	Affected / at Risk (%)	# Events
Total	28/41 (68.3%)
Infections and infestations
Infection - early onset	4/41 (9.8%)
Injury, poisoning and procedural complications
Breast tenderness/pain - early onset	11/41 (26.8%)
Breast tenderness/pain - late onset	4/41 (9.8%)
Erythema - early onset	11/41 (26.8%)
Hematoma/seroma - early onset	5/41 (12.2%)
Skin and subcutaneous tissue disorders
Pigmentation - early onset	8/41 (19.5%)
Telangiectasia - late onset	4/41 (9.8%)
Induration - early onset	6/41 (14.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.