Trial Outcomes & Findings for BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB) (NCT NCT01961531)

NCT ID: NCT01961531

Last Updated: 2022-03-04

Results Overview

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Accuboost APBI 28Gy delivered in 5 daily fractions Accuboost APBI: 28Gy delivered in 5 daily fractions
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accuboost APBI n=40 Participants 28Gy delivered in 5 daily fractions Accuboost APBI: 28Gy delivered in 5 daily fractions
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	26 Participants n=99 Participants
Age, Continuous	67.45 years n=99 Participants
Sex: Female, Male Female	40 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	40 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	39 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	40 participants n=99 Participants

PRIMARY outcome

Timeframe: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Outcome measures

Outcome measures
Measure	Accuboost APBI n=40 Participants 28Gy delivered in 5 daily fractions Accuboost APBI: 28Gy delivered in 5 daily fractions
Number of Patients With Any Toxicity Related to the Radiation Treatment	40 Participants

SECONDARY outcome

Timeframe: annually for 2 years post treatment

Outcome measures

Outcome measures
Measure	Accuboost APBI n=40 Participants 28Gy delivered in 5 daily fractions Accuboost APBI: 28Gy delivered in 5 daily fractions
Number of Participants With Ipsilateral Breast Local Recurrence	2 Participants

Adverse Events

Accuboost APBI

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Accuboost APBI n=40 participants at risk 28Gy delivered in 5 daily fractions Accuboost APBI: 28Gy delivered in 5 daily fractions
General disorders Discomfort	67.5% 27/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Acute Skin Reaction	80.0% 32/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Skin Induration/Fibrosis	20.0% 8/40 • Data was collected from signing of ICF until 5 years post treatment.
General disorders Fatigue	47.5% 19/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Hyperpigmentation	17.5% 7/40 • Data was collected from signing of ICF until 5 years post treatment.
Reproductive system and breast disorders Breast Soreness	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
Musculoskeletal and connective tissue disorders Seroma	5.0% 2/40 • Data was collected from signing of ICF until 5 years post treatment.
General disorders Edema	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
General disorders Shoulder Pain	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
Infections and infestations Contralateral Breast Infection	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Pruritus	5.0% 2/40 • Data was collected from signing of ICF until 5 years post treatment.
Reproductive system and breast disorders Breast Volume/Hypoplasia	27.5% 11/40 • Data was collected from signing of ICF until 5 years post treatment.
Musculoskeletal and connective tissue disorders Fibrosis-cosmesis	7.5% 3/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Telangiectasia	32.5% 13/40 • Data was collected from signing of ICF until 5 years post treatment.
Reproductive system and breast disorders Breast Tenderness	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
Reproductive system and breast disorders Breast Pain	12.5% 5/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Skin Atrophy	7.5% 3/40 • Data was collected from signing of ICF until 5 years post treatment.
Skin and subcutaneous tissue disorders Hypopigmentation	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.
Infections and infestations Folliculitis	2.5% 1/40 • Data was collected from signing of ICF until 5 years post treatment.

Additional Information

Jaroslaw Hepel, MD

BrUOG- Brown University Oncology Research Group

Phone: 401-863-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place