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Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

NCT04679454 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-08-05

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Phase I

To establish the recommended dose defined as the maximum tolerated dose (MTD)The dose-limiting toxicity (DLT) is defined as any G3-G4 event according to NCI CTCAE Version 4.03 scale. Dose escalation is designed as a 3+3 rule-based study. Dose escalation will be initiated from a baseline dose of 18 Gy and increased to reach 21 Gy and 24 Gy. The population size includes 18 patients.

RADIATION

Phase II

The recommended dose from the phase I study is delivered, using Cyberknife in order to evaluate the efficacy measured in terms of pCR rate. The population size includes 61 patients.

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Maria Cristina Leonardi · European Institute of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2026-03-31
Completion
2029-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04679454 on ClinicalTrials.gov