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Trial Outcomes & Findings for Multi-catheter High Dose Rate (HDR) Breast Brachytherapy (NCT NCT00214149)

NCT ID: NCT00214149

Last Updated: 2018-11-05

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

5 years

Results posted on

2018-11-05

Participant Flow

Participant milestones

Participant milestones
Measure
Breast Brachytherapy to 34 Gy
breast brachytherapy to a dose of 34 Gy brachytherapy: breast brachytherapy to 34 Gy
Overall Study
STARTED
127
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
127

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Breast Brachytherapy to 34 Gy
n=127 Participants
breast brachytherapy to a dose of 34 Gy brachytherapy: breast brachytherapy to 34 Gy
Age, Customized
Age 30-39
2 years
n=5 Participants
Age, Customized
Age 40-49
29 years
n=5 Participants
Age, Customized
Age 50-59
35 years
n=5 Participants
Age, Customized
Age 60-69
45 years
n=5 Participants
Age, Customized
Age 70-79
14 years
n=5 Participants
Age, Customized
Age 80-89
2 years
n=5 Participants
Sex: Female, Male
Female
127 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
123 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
124 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
127 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.

Outcome measures

Outcome data not reported

Adverse Events

Breast Brachytherapy to 34 Gy

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana Trask, research coordinator for study

UW Hospital and Clinics

Phone: 608-263-9528

Results disclosure agreements

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