Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients — ABLATIVE-2  

Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT05350722
• Study type: Interventional
• Source: Amsterdam UMC, location VUmc
• Contact: Yasmin Civil, MD
• Phone: 020 4441484
• Email: y.civil@amsterdamumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Completion date: March 2035