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

NCT05350722 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-30

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Single dose ablative radiotherapy

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

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Desirée van den Bongard, MD, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2027-12-31
Completion
2037-12-31

Countries

  • Australia
  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350722 on ClinicalTrials.gov