CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Brachytherapy APBI +2 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/NCT02453737
NCT02453737Phase 2Completed

A Phase II Study of Accelerated 3 Fraction Photon and Proton Partial Breast External Beam Radiotherapy and Partial Breast Brachytherapy for Early Invasive and Noninvasive Breast Cancer

Mayo Clinic·interventional·Posted May 25, 2015·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Brachytherapy APBI, 3D-CRT (photon) APBI, and 1 other intervention for Breast Cancer. Completed, enrolled 170 participants across 3 sites.

Detailed Summary

This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 25, 2015
Enrollment StartJun 16, 2015
Primary CompletionOct 3, 2020
Study CompletionSep 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 11.1 years ago

Interventions

Brachytherapy APBIradiation

3D-CRT (photon) APBIradiation

Proton APBIradiation