RecruitingPhase 2NCT05762900

Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

65 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.


Eligibility

Sex: FEMALEMin Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether an ultra-short (ultra-hypofractionated) course of radiation therapy — delivering the full treatment in fewer, larger doses — is effective and safe for people with low-risk or early-stage breast cancer after surgery. Some patients may also receive a simultaneous boost to the area with the highest risk of recurrence. **You may be eligible if...** - You have been diagnosed with invasive or non-invasive (in situ) breast cancer - You have had breast-conserving surgery (lumpectomy) or mastectomy - Your cancer is at an early stage (no more than T2 and no more than 1 lymph node involved) - Your cancer has not spread to distant parts of the body **You may NOT be eligible if...** - Your cancer has spread to lymph nodes near the collarbone or chest wall - You have had prior chest radiation - You are pregnant - You have serious connective tissue diseases like active scleroderma or lupus 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

RADIATIONUltra-fractionated radiation therapy

5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.


Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

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NCT05762900


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