MedTrace Logo

Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Nanomechanical Biomarker Evaluation

NCT05774678 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-12-26

No results posted yet for this study

Summary

To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer surgery (cancer removal and reconstruction).

Conditions

Interventions

RADIATION

Group 1 (preoperative radiation hypofractionated)

radiation schedules/regimens before your scheduled breast surgery

OTHER

Group 2 (preoperative radiation conventionally fractionated)

radiation schedules/regimens before your scheduled breast surgery

Sponsors & Collaborators

  • Artidis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Benjamin D. Smith, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2026-11-01
Completion
2028-11-01

Countries

  • United States

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 NCT05774678 on ClinicalTrials.gov