Trial Outcomes & Findings for Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery (NCT NCT02526498)

Last Updated: 2023-05-15

Results Overview

Measured by the data collected for toxicity and cosmesis as dichotomous variables. This will be assessed by physical examination at each follow-up visit. To be scored as a serious toxicity counting toward the primary endpoint, the toxicity must have a "probable" or "definite" attribution to the study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

2 years

Results posted on

2023-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (APBI Using HDR Brachytherapy) Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Overall Study NOT COMPLETED	0
Overall Study STARTED	200
Overall Study COMPLETED	200

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (APBI Using HDR Brachytherapy) n=200 Participants Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	135 Participants n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	189 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 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	7 Participants n=5 Participants
Race (NIH/OMB) White	185 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
Region of Enrollment United States	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Treatment (APBI Using HDR Brachytherapy) n=200 Participants Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Number of Participants With Adverse Events Greater Than Grade 2 Serious Toxicity Rate, Defined as Toxicity Greater Than Grade 2 Using Common Terminology Criteria for Adverse Events Version 4.0 Criteria	200 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Data not collected.

The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Descriptive statistics reported.

Outcome measures

Outcome measures
Measure	Treatment (APBI Using HDR Brachytherapy) n=182 Participants Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale	177 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Data not collected.

Assessed using the Kaplan-Meier method. The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. Tests will be declared statistically significant if the calculated P-value was =\< 0.05. All tests appear as 2-sided P-values.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (APBI Using HDR Brachytherapy)

Serious events: 0 serious events

Other events: 165 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (APBI Using HDR Brachytherapy) n=200 participants at risk Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	22.0% 44/200 • Number of events 58 • Adverse events were collected over a period of two years.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	14.5% 29/200 • Number of events 37 • Adverse events were collected over a period of two years.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	9.5% 19/200 • Number of events 19 • Adverse events were collected over a period of two years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	19.5% 39/200 • Number of events 42 • Adverse events were collected over a period of two years.
Skin and subcutaneous tissue disorders Dermatitis radiation	14.5% 29/200 • Number of events 32 • Adverse events were collected over a period of two years.
Skin and subcutaneous tissue disorders Seroma	5.5% 11/200 • Number of events 11 • Adverse events were collected over a period of two years.
Reproductive system and breast disorders Reproductive system and breast disorder	17.5% 35/200 • Number of events 41 • Adverse events were collected over a period of two years.
General disorders Breast Pain	15.0% 30/200 • Number of events 38 • Adverse events were collected over a period of two years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	5.0% 10/200 • Number of events 10 • Adverse events were collected over a period of two years.

Additional Information

Bruce Haffty

Cancer Institute of New Jersey

Phone: 732-235-5203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place