Trial Outcomes & Findings for Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation (NCT NCT02104895)

Results Overview

We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

520 participants

Primary outcome timeframe

5-year

Results posted on

2016-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Whole Breast Irradiation (WBI) Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Overall Study STARTED	260	260
Overall Study COMPLETED	260	246
Overall Study NOT COMPLETED	0	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Whole Breast Irradiation (WBI) Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Overall Study Withdrawal by Subject	0	14

Baseline Characteristics

Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Whole Breast Irradiation (WBI) n=260 Participants Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) n=260 Participants Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)	Total n=520 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	158 Participants n=5 Participants	142 Participants n=7 Participants	300 Participants n=5 Participants
Age, Categorical >=65 years	102 Participants n=5 Participants	118 Participants n=7 Participants	220 Participants n=5 Participants
Sex: Female, Male Female	260 Participants n=5 Participants	260 Participants n=7 Participants	520 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Italy	260 participants n=5 Participants	260 participants n=7 Participants	520 participants n=5 Participants

PRIMARY outcome

Timeframe: 5-year

We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"

Outcome measures

Outcome measures
Measure	Whole Breast Irradiation (WBI) n=260 Participants Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) n=260 Participants Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Ipsilateral Breast Tumor Recurrence	1.4 percentage of participants	1.5 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced "Acute skin toxicity ≥ grade 2

Outcome measures

Outcome measures
Measure	Whole Breast Irradiation (WBI) n=260 Participants Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) n=260 Participants Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Acute Skin Toxicity	37.7 percentage of participants	2 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects

Outcome measures

Outcome measures
Measure	Whole Breast Irradiation (WBI) n=260 Participants Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) n=260 Participants Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Excellent Cosmesis	89.6 percentage of participants	95.1 percentage of participants

Adverse Events

Whole Breast Irradiation (WBI)

Serious events: 0 serious events

Other events: 173 other events

Deaths: 0 deaths

Partial Breast Irradiation (APBI)

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Whole Breast Irradiation (WBI) n=260 participants at risk Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)	Partial Breast Irradiation (APBI) n=246 participants at risk Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
Skin and subcutaneous tissue disorders acute skin toxicity, any grade	66.5% 173/260 • 5-years Acute and late skin toxicity, any grade	19.9% 49/246 • 5-years Acute and late skin toxicity, any grade
Skin and subcutaneous tissue disorders late skin toxicity, any grade	11.2% 29/260 • 5-years Acute and late skin toxicity, any grade	4.5% 11/246 • 5-years Acute and late skin toxicity, any grade

Additional Information

Dr. Icro Meattini

Radiation-Oncology Unit, AOU Careggi, Florence University, Florence, Italy

Phone: +39055794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place