RecruitingPhase 2NCT04084730

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

280 participants

Start Date

Aug 30, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.


Eligibility

Sex: FEMALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new shorter radiation approach for early-stage breast cancer — delivering partial breast radiation in just 3 days instead of several weeks. The radiation targets only the area where the tumor was removed, rather than the whole breast. **You may be eligible if...** - You are a woman aged 45 or older (some women 40–44 may also qualify) - You have been diagnosed with early-stage invasive breast cancer or DCIS (a non-invasive form), with the tumor measuring less than 3 cm - You had a lumpectomy with clear margins (no cancer cells at the edge of the removed tissue) - You are not pregnant **You may NOT be eligible if...** - The cancer has spread to other parts of your body - You are pregnant or breastfeeding - You have cancer in multiple areas of the breast or in both breasts - You had previous radiation to the chest or breast - You have been tested and found to carry a BRCA gene mutation - You have had breast implants in the breast being treated - You have conditions like lupus or scleroderma that make radiation risky 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

RADIATIONAccelerated Partial Breast Irradiation

Treatment will consist of APBI delivered using external beam RT techniques to a dose of 24 Gy in 3 fractions of 8.0 Gy delivered on consecutive weekdays


Locations(9)

Norwalk Hospital

Norwalk, Connecticut, United States

Baptist Alliance Miami Cancer Institute

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04084730


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