Trial Outcomes & Findings for Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ (NCT NCT00290654)

NCT ID: NCT00290654

Last Updated: 2017-12-28

Results Overview

Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 1 year after treatment
• Results posted on: 2017-12-28

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MammoSite Treatment Group n=41 Participants 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.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Number of Patients With Ipsilateral Breast Tumor Recurrence	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Number of Patients With Ipsilateral Breast Tumor Recurrence	4 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Patients Who Experienced Complications	65.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Patients Who Experienced Complications	24.4 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent	100 percentage of physicians

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent	86.7 percentage of physicians

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent	96.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Evaluable Patients n=41 Participants Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent	92.3 percentage of participants

Adverse Events

MammoSite Treatment Group

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure

MammoSite Treatment Group n=41 participants at risk 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.

Skin and subcutaneous tissue disorders Skin ulceration

2.4% 1/41

Other adverse events

Measure	MammoSite Treatment Group n=41 participants at risk 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.
Injury, poisoning and procedural complications Breast tenderness/pain - early onset	26.8% 11/41
Injury, poisoning and procedural complications Breast tenderness/pain - late onset	9.8% 4/41
Injury, poisoning and procedural complications Erythema - early onset	26.8% 11/41
Injury, poisoning and procedural complications Hematoma/seroma - early onset	12.2% 5/41
Infections and infestations Infection - early onset	9.8% 4/41
Skin and subcutaneous tissue disorders Pigmentation - early onset	19.5% 8/41
Skin and subcutaneous tissue disorders Telangiectasia - late onset	9.8% 4/41
Skin and subcutaneous tissue disorders Induration - early onset	14.6% 6/41

Additional Information

Todd Tuttle, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-625-2991

Email: tuttl005@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place