CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
APBI +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06007118
NCT06007118N/ACompleted

Adjuvant Partial-breast Irradiation of Early-stage Breast Cancer Using Stereotactic Body Radiation Therapy

Masaryk Memorial Cancer Institute·interventional·Posted Aug 23, 2023·Updated Aug 23, 2023

In Brief

A clinical study evaluating APBI and WBI for Early-stage Breast Cancer. Completed, enrolled 85 participants across 1 site.

Detailed Summary

The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 23, 2023
Enrollment StartMay 1, 2019
Primary CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 2.9 years ago

Interventions

APBIradiation

accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)

WBIradiation

accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)