RecruitingNot ApplicableNCT05350722

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


Sponsor

Amsterdam UMC, location VUmc

Enrollment

100 participants

Start Date

Aug 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a single dose of targeted radiation (partial breast irradiation) given before surgery for women with small, low-risk breast cancer. The idea is that treating the tumor site with one dose of radiation before removing it may be just as effective as standard radiation after surgery, while being more convenient. **You may be eligible if...** - You are a woman aged 50 or older - You have a small (stage T1N0), single-focus breast cancer detected on imaging - Your tumor is hormone receptor-positive (ER+) and HER2-negative - The tumor is grade 1 or 2 (low to intermediate grade) and is a non-lobular invasive cancer - Your lymph nodes show no cancer spread (negative sentinel node) **You may NOT be eligible if...** - You carry a BRCA1, BRCA2, or CHEK2 gene mutation - The cancer has spread to distant parts of the body - You have had breast cancer or DCIS before - You have a connective tissue disease (like lupus or scleroderma) - Your tumor has an extensive in-situ (DCIS) component or is lobular carcinoma - You need chemotherapy or HER2-targeted therapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONSingle 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


Locations(7)

GenesisCare

Sydney, Australia

Flevoziekenhuis

Almere Stad, Netherlands

Ziekenhuis Amstelland

Amstelveen, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Radboud UMC

Nijmegen, Netherlands

Zaans Medisch Centrum

Zaandam, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05350722


Related Trials