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Trial Outcomes & Findings for Mammosite Breast Brachytherapy Optimization in the Treatment of Breast Carcinoma (NCT NCT00611624)

NCT ID: NCT00611624

Last Updated: 2017-05-16

Results Overview

Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

one year

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure
Five Days of Mammosite Therapy
Five Days of Mammosite Therapy (Radiotherapy)
Overall Study
STARTED
28
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

n = 24

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Five Days of Mammosite Therapy
n=28 Participants
Age, Categorical
<=18 years
0 Participants
n=28 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=28 Participants
Age, Categorical
>=65 years
14 Participants
n=28 Participants
Sex: Female, Male
Female
28 Participants
n=28 Participants
Sex: Female, Male
Male
0 Participants
n=28 Participants
Tumor Stage
Tis
4 Participants
n=28 Participants
Tumor Stage
T1mi
1 Participants
n=28 Participants
Tumor Stage
T1a
2 Participants
n=28 Participants
Tumor Stage
T1b
10 Participants
n=28 Participants
Tumor Stage
T1c
11 Participants
n=28 Participants
Histology
Ductal carcinoma in situ (DCIS)
4 Participants
n=28 Participants
Histology
Invasive ductal carcinoma
19 Participants
n=28 Participants
Histology
Invasive lobular carcinoma
3 Participants
n=28 Participants
Histology
Invasive tubulolobular carcinoma
1 Participants
n=28 Participants
Histology
Invasive cribriform carcinoma
1 Participants
n=28 Participants
Lymph node evaluation
Sentinel lymph node
24 Participants
n=24 Participants • n = 24
Lymph node evaluation
Axillary lymph node dissection
0 Participants
n=24 Participants • n = 24
Size of invasive component
1.0 centimeters (cm)
n=28 Participants
Size of in situ component
0.8 centimeters (cm)
n=28 Participants
Size of in situ component (DCIS patients)
0.8 centimeters (cm)
n=4 Participants • This was only measured in DCIS patients (n=4).
estrogen receptor (ER)
positive
28 Participants
n=28 Participants
estrogen receptor (ER)
negative
0 Participants
n=28 Participants
progesterone receptor (PR)
positive
24 Participants
n=28 Participants
progesterone receptor (PR)
negative
4 Participants
n=28 Participants
HER2/neu status (invasive disease only)
positive
0 Participants
n=24 Participants • Only counted in those with invasive disease (n=24).
HER2/neu status (invasive disease only)
negative
24 Participants
n=24 Participants • Only counted in those with invasive disease (n=24).
lymphovascular space invasion (LVSI)
yes
0 Participants
n=28 Participants
lymphovascular space invasion (LVSI)
no
28 Participants
n=28 Participants

PRIMARY outcome

Timeframe: one year

Population: 26 participants completed the 1 year assessment.

Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.

Outcome measures

Outcome measures
Measure
Five Days of Mammosite Therapy
n=26 Participants
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
Grade 2 Toxicity
2 Participants
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
Grade 3 Toxicity
0 Participants
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
Grade 4 Toxicity
0 Participants
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
Grade 5 Toxicity
0 Participants
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
Did not experience >= Grade 2 Toxicity
24 Participants

SECONDARY outcome

Timeframe: Upon completion of study

These data were not collected and were not summarized in this study. Results are not available.

Outcome measures

Outcome data not reported

Adverse Events

Five Days of Mammosite Therapy

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Five Days of Mammosite Therapy
n=28 participants at risk
General disorders
Pain
7.1%
2/28 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders
Fibrosis
25.0%
7/28 • Number of events 7 • 1 year
Vascular disorders
Telangiectasia
7.1%
2/28 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders
Skin
7.1%
2/28 • Number of events 2 • 1 year

Additional Information

Kira F. Pavlik, CCRP Clinical Research Coordinator Therapeutic Radiology

Yale Comprehensive Cancer Center

Phone: (203) 737-2587

Results disclosure agreements

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