Trial Outcomes & Findings for Evaluation of Accelerated Partial Breast Brachytherapy (NCT NCT00593346)

NCT ID: NCT00593346

Last Updated: 2015-06-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: 2 years after treatment completion
• Results posted on: 2015-06-29

Participant Flow

The study opened to participant enrollment on March 12, 2004 and closed to participant enrollment on 12/22/2008.

Participant milestones

Measure	Accelerated Partial Breast Bracytherapy Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Overall Study STARTED	151
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Accelerated Partial Breast Brachytherapy

Baseline characteristics by cohort

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants
Race Caucasian	128 participants n=5 Participants
Race African-American	23 participants n=5 Participants
Residence at diagnosis Urban area	111 participants n=5 Participants
Residence at diagnosis Urban cluster	25 participants n=5 Participants
Residence at diagnosis Rural	15 participants n=5 Participants
Tumor location Upper outer quadrant	54 participants n=5 Participants
Tumor location Upper inner quadrant	46 participants n=5 Participants
Tumor location Lower outer quadrant	30 participants n=5 Participants
Tumor location Lower inner quadrant	21 participants n=5 Participants
Pathologic tumor stage Tis	28 participants n=5 Participants
Pathologic tumor stage T1mic	1 participants n=5 Participants
Pathologic tumor stage T1a	19 participants n=5 Participants
Pathologic tumor stage T1b	52 participants n=5 Participants
Pathologic tumor stage T1c	38 participants n=5 Participants
Pathologic tumor stage T2	13 participants n=5 Participants
Sentinel lymph node biopsy Yes	122 participants n=5 Participants
Sentinel lymph node biopsy No	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years after treatment completion

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Local Control Using Ipsilateral Breast Tumor Recurrence Rates	.7 percentage of participants

PRIMARY outcome

Timeframe: 5 years after treatment completion

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates	3.4 percentage of participants

PRIMARY outcome

Timeframe: 2 years after treatment completion

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Local Control Using Disease-free Survival Rates	99.3 percentage of participants

PRIMARY outcome

Timeframe: 5 years after treatment completion

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Local Control Using Disease-free Survival Rates	94.4 percentage of participants

SECONDARY outcome

Timeframe: 2 years

-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Quality of Life Completion 6-8 weeks	99 percentage of participants
Quality of Life Completion 3-4 months	95 percentage of participants
Quality of Life Completion 6-8 months	91 percentage of participants
Quality of Life Completion 1 year	88 percentage of participants
Quality of Life Completion 2 years	74 percentage of participants

SECONDARY outcome

Timeframe: 3 years after completion of therapy

Population: 82 participants had cosmetic outcome data through 3 years of follow-up.

• Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.
• The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=82 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Excellent-good Cosmetic Outcomes - Patient Reported Pre-treatment	92 percentage of participants
Excellent-good Cosmetic Outcomes - Patient Reported 3-4 months after treatment	91 percentage of participants
Excellent-good Cosmetic Outcomes - Patient Reported 2 years	87 percentage of participants
Excellent-good Cosmetic Outcomes - Patient Reported 3 years	92 percentage of participants

SECONDARY outcome

Timeframe: 3 years after completion of therapy

Population: 82 participants had cosmetic outcome data through 3 years of follow-up.

• Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).
• The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=82 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Excellent-good Cosmetic Outcomes - Physician Reported Pre-treatment	97 percentage of participants
Excellent-good Cosmetic Outcomes - Physician Reported 3-4 months after treatment	97 percentage of participants
Excellent-good Cosmetic Outcomes - Physician Reported 2 years	94 percentage of participants
Excellent-good Cosmetic Outcomes - Physician Reported 3 years	94 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: 82 participants had cosmetic outcome data through 3 years of follow-up.

-Patients filled out a form "Patient Evaluation of the Treated Breast". On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:

• caused mostly by radiation
• caused by both the radiation and surgery, but mostly by the radiation
• caused by both the radiation and surgery, but mostly by the surgery
• caused mostly by the surgery
• can't judge which treatment caused the change
• there are no changes

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=82 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported Radiation	16.5 percentage of participants
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported Surgery	57 percentage of participants
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported Unsure	19 percentage of participants
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported No cosmetic changes	7.5 percentage of participants

SECONDARY outcome

Timeframe: Pre-treatment and 3 years

Population: 82 participants had cosmetic outcome data through 3 years of follow-up.

-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=82 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA) Pre-treatment	7.35 percentage of breast retraction Interval 6.49 to 8.21
Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA) 3 years	7.64 percentage of breast retraction Interval 6.68 to 8.6

SECONDARY outcome

Timeframe: 5 years after treatment completion

As defined by number of participants who experienced breast infection and symptomatic fat necrosis.

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Presence or Absence of Complications Breast infection	6 participants
Presence or Absence of Complications Fat necrosis (symptomatic)	19 participants

SECONDARY outcome

Timeframe: 5 years after treatment completion

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment	4 participants

SECONDARY outcome

Timeframe: Up to 1 year from completion of therapy

RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.

Outcome measures

Measure	Accelerated Partial Breast Brachytherapy n=151 Participants Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Frequency of Grade 3-4 Toxicities Acute skin - Grade 3/4	1 participants
Frequency of Grade 3-4 Toxicities Acute breast infection - Grade 3/4	2 participants
Frequency of Grade 3-4 Toxicities Acute subcutaneous - Grade 3/4	0 participants
Frequency of Grade 3-4 Toxicities Late skin - Grade 3/4	0 participants
Frequency of Grade 3-4 Toxicities Late subcutaneous	0 participants
Frequency of Grade 3-4 Toxicities Late heart - Grade 3/4	0 participants
Frequency of Grade 3-4 Toxicities Late pulmonary - Grade 3/4	0 participants

Adverse Events

Accelerated Partial Breast Bracytherapy

Serious events: 0 serious events

Other events: 151 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Accelerated Partial Breast Bracytherapy n=151 participants at risk Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.
Skin and subcutaneous tissue disorders Acute skin	38.4% 58/151 • Adverse events were collected from the start of treatment through 1 year after completion of treatment.
Infections and infestations Acute breast infection	4.0% 6/151 • Adverse events were collected from the start of treatment through 1 year after completion of treatment.
Skin and subcutaneous tissue disorders Acute subcutaneous	8.6% 13/151 • Adverse events were collected from the start of treatment through 1 year after completion of treatment.
Skin and subcutaneous tissue disorders Late skin	23.8% 36/151 • Adverse events were collected from the start of treatment through 1 year after completion of treatment.
Skin and subcutaneous tissue disorders Late subcutaneous	29.1% 44/151 • Adverse events were collected from the start of treatment through 1 year after completion of treatment.

Additional Information

Imran Zoberi, M.D.

Washington University School of Medicine

Phone: 314-362-8525

Email: izoberi@radonc.wustl.edu

Results disclosure agreements

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