RecruitingNot ApplicableNCT07814365

PBI for Low-risk Breast Cancer

A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer


Sponsor

Fudan University

Enrollment

818 participants

Start Date

Sep 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 1-week PBI and 3-week PBI for people with early stage breast cancer. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 75 Years.

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

RADIATION3-week PBI

40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily

RADIATION1-week PBI

26Gy/5Fx/1w, 5.2Gy/Fx, once daily


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07814365


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