Trial Outcomes & Findings for Study of Preoperative Boost Radiotherapy (NCT NCT02482389)

Last Updated: 2022-04-14

Results Overview

Change from baseline rates of cosmesis at 3 years post-treatment as measured by the NRG Oncology cosmesis scale. The scale is scored from 1 (excellent) to 4 (poor) with a lower number representing better physical appearance.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

baseline to 3 years post radiation therapy

Results posted on

2022-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm 7 Gray (Gy) Fraction of Radiotherapy All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery. Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Preoperative Boost Radiotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm 7 Gray (Gy) Fraction of Radiotherapy n=3 Participants All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery. Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Age, Continuous	51.67 years STANDARD_DEVIATION 3.79 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Cosmesis evaluation	1 units on a scale STANDARD_DEVIATION 0 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 3 years post radiation therapy

Outcome measures

Outcome measures
Measure	Single Arm 7 Gray (Gy) Fraction of Radiotherapy n=3 Participants All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery. Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Change in Cosmesis Evaluations Using the NRG Oncology Cosmesis Scale	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 5 years

Population: Data not collected.

Blood collected pre and post treatment will be used to explore the biologic response to radiotherapy by comparing changes in circulating cell-free DNA expression pre and post-radiotherapy:

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Patient-reported Quality of Life as measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B) at 3 years post-treatment. The FACT-B includes 35 items scored on a Likert-type scale from 0 (not at all) to 4 (very much) with a total scale range of 0-140 and a lower total score indicating a better outcome. Only the total scale score is reported; subscales scores are not reported.

Outcome measures

Outcome measures
Measure	Single Arm 7 Gray (Gy) Fraction of Radiotherapy n=3 Participants All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery. Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Quality of Life as Measured by Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire	11.7 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 5-10 years

Population: Data will not be collected and reported as the study was terminated prematurely due to poor accrual.

Document local control in the treated breast relative to historical controls with annual clinical exam and imaging studies. Local control is defined as the time from start of treatment to date of local recurrence estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm 7 Gray (Gy) Fraction of Radiotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Arm 7 Gray (Gy) Fraction of Radiotherapy n=3 participants at risk All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery. Single fraction of 7 Gy: All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
Reproductive system and breast disorders Breast pain	66.7% 2/3 • Number of events 4 • 3 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	66.7% 2/3 • Number of events 3 • 3 years
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	66.7% 2/3 • Number of events 4 • 3 years
Injury, poisoning and procedural complications Seroma	33.3% 1/3 • Number of events 1 • 3 years
Reproductive system and breast disorders Other	33.3% 1/3 • Number of events 1 • 3 years
Injury, poisoning and procedural complications Bruising	66.7% 2/3 • Number of events 2 • 3 years
Injury, poisoning and procedural complications Other	33.3% 1/3 • Number of events 1 • 3 years

Additional Information

Joan Cahill

Duke University Health System

Phone: (919) 668-5211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place