Trial Outcomes & Findings for TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry (NCT NCT01440010)

Results Overview

The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate

Recruitment status

COMPLETED

Target enrollment

1133 participants

Primary outcome timeframe

5 years

Results posted on

2025-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	IORT With 50 kV X-rays, 20 Gy Boost with 20 Gy during BCS, EBRT with 46-50 Gy IORT with 50 kV x-rays, 20 Gy: Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Overall Study STARTED	1133
Overall Study COMPLETED	902
Overall Study NOT COMPLETED	231

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IORT Boost With 20 Gy and Standard Whole Breast Irradition n=902 Participants All patients gave their informed consent prior to surgery and were planned for an anticipated boost immediately after tumor resection. Additionally, all patients were planned for standard whole breast radiotherapy with external beam radiation (EBRT). IORT with low-kV x-rays was given immediately after tumor resection into the tumorbed with 12-20 Gy as a single fraction with the INTRABEAM® system. EBRT was given according to standard of care procedures with conventional or hypofractioned schedules.
Age, Continuous	61 years n=902 Participants
Sex: Female, Male Female	902 Participants n=902 Participants
Sex: Female, Male Male	0 Participants n=902 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Planned IORT Boost plus whole breast irradiation

The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate

Outcome measures

Outcome measures
Measure	IORT Boost n=902 Participants Planned IORT as Boost plus whole breast irradiation
Number of Patients With Local Recurrence	10 participants

SECONDARY outcome

Timeframe: 84 months

Population: Chronic higher grade fibrosis was defined as fibrosis grade 2 or higher occuring at least 3 times during follow-up

Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) and oncological data took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs).

Outcome measures

Outcome measures
Measure	IORT Boost n=813 Participants Planned IORT as Boost plus whole breast irradiation
Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost	132 Participants

Adverse Events

IORT Boost With 20 Gy and Standard Whole Breast Irradition

Serious events: 0 serious events

Other events: 83 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IORT Boost With 20 Gy and Standard Whole Breast Irradition n=902 participants at risk All patients gave their informed consent prior to surgery and were planned for an anticipated boost immediately after tumor resection. Additionally, all patients were planned for standard whole breast radiotherapy with external beam radiation (EBRT). IORT with low-kV x-rays was given immediately after tumor resection into the tumorbed with 12-20 Gy as a single fraction with the INTRABEAM® system. EBRT was given according to standard of care procedures with conventional or hypofractioned schedules.
Skin and subcutaneous tissue disorders Erythema	4.4% 40/902 • Number of events 40 • 5 years
Skin and subcutaneous tissue disorders Palpable seroma	9.2% 83/902 • Number of events 83 • 5 years

Additional Information

PD Dr. med. Elena Sperk

Medical Faculty Mannheim, Heidelberg University

Phone: +496213838624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place