Trial Outcomes & Findings for MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (NCT NCT00586326)

Last Updated: 2012-11-06

Results Overview

Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

133 participants

Primary outcome timeframe

Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.

Results posted on

2012-11-06

Participant Flow

Per the protocol, a total of 125 subjects were to be enrolled at 10-15 nationwide centers. A total of 133 subjects were enrolled at 12 nationwide centers. Patients with DCIS electing to undergo breast conserving therapy with radiation therapy were screened for enrollment.

Consented patients who were willing to enroll were evaluated prior to surgery. The lumpectomy was performed per the usual standard of care. The MammoSite applicator could be placed at the time of lumpectomy surgery or post-surgery in a separate procedure if adequate evacuated cavity was available as assessed by ultrasound.

Participant milestones

Participant milestones
Measure	Enrolled Women with DCIS who were willing to enroll and consented
Enrollment to Device Placement-Enrolled STARTED	133
Enrollment to Device Placement-Enrolled COMPLETED	118
Enrollment to Device Placement-Enrolled NOT COMPLETED	15
Device Placed toTreatment-ITT STARTED	118
Device Placed toTreatment-ITT COMPLETED	100
Device Placed toTreatment-ITT NOT COMPLETED	18
Treated Through 5-yr Follow Up-Treated STARTED	100
Treated Through 5-yr Follow Up-Treated COMPLETED	74
Treated Through 5-yr Follow Up-Treated NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled Women with DCIS who were willing to enroll and consented
Enrollment to Device Placement-Enrolled Skin Distance	6
Enrollment to Device Placement-Enrolled Cavity Conformance	4
Enrollment to Device Placement-Enrolled Microinvasion	2
Enrollment to Device Placement-Enrolled Physician Decision	1
Enrollment to Device Placement-Enrolled Withdrawal by Subject	1
Enrollment to Device Placement-Enrolled Other	1
Device Placed toTreatment-ITT Skin Distance	7
Device Placed toTreatment-ITT Cavity Conformance	6
Device Placed toTreatment-ITT Microinvasion	1
Device Placed toTreatment-ITT Positive Margins	3
Device Placed toTreatment-ITT Physician Decision	1
Treated Through 5-yr Follow Up-Treated Clinical Reason	1
Treated Through 5-yr Follow Up-Treated Death	2
Treated Through 5-yr Follow Up-Treated Medical Reason	2
Treated Through 5-yr Follow Up-Treated Withdrawal by Subject	5
Treated Through 5-yr Follow Up-Treated Lost to Follow-up	14
Treated Through 5-yr Follow Up-Treated Other	2

Baseline Characteristics

MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated n=100 Participants Subjects enrolled with device placed and treated with partial breast irradiation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age Continuous	61.3 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.

Outcome measures

Outcome measures
Measure	Treated n=100 Participants Subjects enrolled with device placed and treated with partial breast irradiation	Good Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years	Fair Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years	Poor Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
Local Control Rate for Follow-up Period of 5 Years.	99 percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: At 5 Years

Outcome measures

Outcome measures
Measure	Treated n=100 Participants Subjects enrolled with device placed and treated with partial breast irradiation	Good Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years	Fair Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years	Poor Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
Overall Survival	97.7 participants Interval 94.6 to 100.0	—	—	—

SECONDARY outcome

Timeframe: At 5 Years

Outcome measures

Outcome measures
Measure	Treated n=100 Participants Subjects enrolled with device placed and treated with partial breast irradiation	Good Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years	Fair Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years	Poor Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
Cause Specific Survival	100.0 participants Interval 100.0 to 100.0	—	—	—

SECONDARY outcome

Timeframe: At 5 Years

Outcome measures

Outcome measures
Measure	Treated n=100 Participants Subjects enrolled with device placed and treated with partial breast irradiation	Good Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years	Fair Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years	Poor Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
Disease Free Survival	98.9 participants Interval 96.7 to 100.0	—	—	—

SECONDARY outcome

Timeframe: At 5 Years

Population: Subjects with Cosmetic Evaluation at 5 Years

As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Outcome measures

Outcome measures
Measure	Treated n=47 Participants Subjects enrolled with device placed and treated with partial breast irradiation	Good n=47 Participants Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years	Fair n=47 Participants Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years	Poor n=47 Participants Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
Cosmetic Evaluations Over Time	42.6 percentage of subjects	44.7 percentage of subjects	12.8 percentage of subjects	0.0 percentage of subjects

Adverse Events

Intent to Treat

Serious events: 6 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intent to Treat n=118 participants at risk Enrolled subjects with MammoSite device placed
Vascular disorders Cerebral Vascular Accident	1.7% 2/118 • Number of events 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer with metastases to the brain	0.85% 1/118 • Number of events 1
Reproductive system and breast disorders Abnormal uterine bleeding	0.85% 1/118 • Number of events 1
Infections and infestations Cellulitis	0.85% 1/118 • Number of events 1
Infections and infestations Infection	0.85% 1/118 • Number of events 1

Other adverse events

Other adverse events
Measure	Intent to Treat n=118 participants at risk Enrolled subjects with MammoSite device placed
Injury, poisoning and procedural complications Seroma	32.2% 38/118
Infections and infestations Infection	3.4% 4/118
General disorders Fat Necrosis	11.9% 14/118
Skin and subcutaneous tissue disorders Telangiectasia	18.6% 22/118
General disorders Fibrosis	34.7% 41/118
General disorders Induration	25.4% 30/118
Reproductive system and breast disorders Breast Pain	24.6% 29/118
Skin and subcutaneous tissue disorders Retraction	7.6% 9/118
Injury, poisoning and procedural complications Radiation Dermatitis	5.9% 7/118
Skin and subcutaneous tissue disorders Hyperpigmentation	16.1% 19/118
Musculoskeletal and connective tissue disorders Rib pain	1.7% 2/118

Additional Information

Nancy Chenette, Director, Clinical Affairs

Hologic, Inc.

Phone: 508-263-8770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60