CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 100 target
Drug / intervention
Single dose ablative radiotherapyradiation
Likely dose
Not stated in record
Key inclusion· 10
  • Females at least 50 years of age
  • Unifocal cT1N0 breast cancer on mammography, ultrasound and MRI
  • Indication for endocrine therapy per Dutch National Oncoline Guidelines or hospital protocols
  • Bloom-Richardson grade 1 or 2
Key exclusion· 12
  • Legal incapacity
  • BRCA1, BRCA2 or CHEK2 gene mutation
  • Distant metastasis
  • Previous history of breast cancer or DCIS

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

Search/NCT05350722
NCT05350722N/ARecruitingOn TrackUpdated 18mo ago
Long Recruiting

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

Amsterdam UMC, location VUmc·interventional·Posted Apr 28, 2022·Updated Dec 30, 2024

In Brief

A clinical study evaluating Single dose ablative radiotherapy for Breast Cancer. Currently recruiting, targeting 100 participants across 7 sites in 2 countries.

Detailed Summary

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Netherlands

Timeline

N/ARecruiting
20222023202420252026202720282029203020312032203320342035203620372038
First PostedApr 28, 2022
Enrollment StartAug 24, 2022
Primary CompletionDec 1, 2027
Study CompletionDec 1, 2037
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 4.2 years agoPrimary completion in 1.4 years

Interventions

Single dose ablative radiotherapyradiation

Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation