Trial Outcomes & Findings for Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® (NCT NCT01448447)

Last Updated: 2021-07-15

Results Overview

* Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. * Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. * Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

5 years

Results posted on

2021-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sole Method patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Overall Study STARTED	20	0
Overall Study COMPLETED	20	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sole Method n=20 Participants patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	—	14 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	—	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 11 patients within sole method arm were lost to follow-up prior to 5 year follow-up period.

Outcome measures

Outcome measures
Measure	Sole Method n=9 Participants patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Ipsilateral Recurrence Rate	0 participants	—

SECONDARY outcome

Timeframe: 6 months after treatment, then annually for 5 years

Population: No patient information was collected for boost method arm as no patients were enrolled into boost method arm. 11 participants in sole method arm were lost to follow-up over 5 year period.

Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation

Outcome measures

Outcome measures
Measure	Sole Method n=20 Participants patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Cosmetic Results Number of pts with "excellent" cosmetic results, 1 year post treatment	4 Participants	0 Participants
Cosmetic Results Number of pts with "good" cosmetic results, 1 year post treatment	14 Participants	0 Participants
Cosmetic Results Number of pts with "poor" cosmetic results, 1 year post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "fair" cosmetic results, 1 year post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "fair" cosmetic results, 2 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "poor" cosmetic results, 2 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "excellent" cosmetic results, 3 years post treatment	4 Participants	0 Participants
Cosmetic Results Number of pts with "good" cosmetic results, 3 years post treatment	10 Participants	0 Participants
Cosmetic Results Number of pts with "excellent" cosmetic results, 4 years post treatment	4 Participants	0 Participants
Cosmetic Results Number of pts with "good" cosmetic results, 4 years post treatment	8 Participants	0 Participants
Cosmetic Results Number of pts with "fair" cosmetic results, 4 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "poor" cosmetic results, 4 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "excellent" cosmetic results, 5 years post treatment	3 Participants	0 Participants
Cosmetic Results Number of pts with "good" cosmetic results, 5 years post treatment	6 Participants	0 Participants
Cosmetic Results Number of pts with "excellent" cosmetic results, 2 years post treatment	4 Participants	0 Participants
Cosmetic Results Number of pts with "good" cosmetic results, 2 years post treatment	12 Participants	0 Participants
Cosmetic Results Number of pts with "fair" cosmetic results, 3 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "poor" cosmetic results, 3 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "fair" cosmetic results, 5 years post treatment	0 Participants	0 Participants
Cosmetic Results Number of pts with "poor" cosmetic results, 5 years post treatment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during therapy, 6 weeks after completion of therapy, and additionally as needed

Population: No patient information was collected for boost method arm as no patients were enrolled into boost method arm of study.

The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures.

Outcome measures

Outcome measures
Measure	Sole Method n=20 Participants patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Toxicity Measured Through Adverse Event Incidence	0 Participants	0 Participants

Adverse Events

Sole Method

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Boost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sole Method n=20 participants at risk patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days	Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Skin and subcutaneous tissue disorders Cellulitis	5.0% 1/20 • Number of events 1 • Adverse events will be collected during follow-up visits non-systematically over the course of 5 years beginning from procedure. Adverse event information not collected from boost method arm patients, as there were no patients enrolled for the boost method arm.	— 0/0 • Adverse events will be collected during follow-up visits non-systematically over the course of 5 years beginning from procedure. Adverse event information not collected from boost method arm patients, as there were no patients enrolled for the boost method arm.

Additional Information

Dr. Robert Frazier

Mercy

Phone: 314-251-6844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place