Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title: Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer

Status Recruiting

Clinical Trial Summary

This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

Clinical Trial Description

The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system.

(ii)The clinical section is organized in two studies: a phase I dose escalation study to identify the maximum tolerated dose (MTD) delivering 18 Gy, 21 Gy and 24 Gy in single fraction and a phase II study to evaluate the rate of pathological complete response (pCR) when a dose level is chosen according to the results of the previous phase I study.

Study population includes patients affected by cT1-T2 (up to 2.5 cm) cN0, adenocarcinoma of the breast, diagnosed with conventional workup. Surgical tumor removal will be scheduled after 4-8 weeks after radioablation. Whole breast radiation therapy without boost will be performed after surgery. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT04679454
• Study type: Interventional
• Source: European Institute of Oncology
• Contact: Maria Cristina Leonardi, MD
• Phone: +39 02 57489037
• Email: cristina.leonardi@ieo.it
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 31, 2021
• Completion date: March 2029