RecruitingPhase 3NCT05774678

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

126 participants

Start Date

Apr 5, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two radiation delivery schedules — a shorter, higher-dose-per-session approach (hypofractionated) versus the traditional longer course (conventional fractionation) — given before mastectomy in people with locally advanced breast cancer who plan to have immediate reconstruction using their own body tissue (called autologous reconstruction). **You may be eligible if...** - You are 18 or older with invasive breast cancer requiring mastectomy - Your cancer is locally advanced (stage T3-T4c) or involves lymph nodes (N1-N3) - You are planning to have mastectomy with immediate autologous (tissue-based) reconstruction - You have not yet had mastectomy at the time of enrollment **You may NOT be eligible if...** - You are planning implant-based (rather than tissue-based) reconstruction - Your cancer has spread to distant organs (unless specific IBC criteria are met) - You have previous radiation to the chest area - You cannot tolerate the planned radiation or surgery 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.

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Interventions

RADIATIONGroup 1 (preoperative radiation hypofractionated)

radiation schedules/regimens before your scheduled breast surgery

OTHERGroup 2 (preoperative radiation conventionally fractionated)

radiation schedules/regimens before your scheduled breast surgery


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05774678


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