RecruitingNot ApplicableNCT05592938

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)


Sponsor

University Health Network, Toronto

Enrollment

171 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a focused re-irradiation approach (called ultra-hypofractionated partial breast re-irradiation) for women whose breast cancer has come back in the same breast after prior radiation. Rather than treating the whole breast again, this approach targets only the affected area with fewer, larger doses. **You may be eligible if...** - You are over 18 and have had a breast cancer recurrence (or a new primary tumor in the same breast) after prior radiation - The tumor is less than 3 cm and has been completely removed with clear margins - It has been more than 5 years since your previous radiation treatment - Your lymph nodes are not involved and there is no spread to other parts of the body **You may NOT be eligible if...** - Your cancer is present in multiple areas of the breast (multicentric disease) - You have lobular carcinoma only (a specific breast cancer subtype) - You have active serious medical conditions such as lupus or scleroderma - Your cancer has spread to lymph nodes or distant sites 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

RADIATIONrPBI

External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week


Locations(17)

NYU Langone Health

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Virgina Community University Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

A.C.Camargo Cancer Center

São Paulo, São Paulo, Brazil

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

London Health Science Centre - Verspeeten Family Cancer Centre

London, Ontario, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CHU de Québec-Université Laval

Montreal, Quebec, Canada

Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Clinica IRAM

Vitacura, Santiago Metropolitan, Chile

Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel

AOU Careggi - Florence University Hospital

Florence, Italy

King Hussein Cancer Centre

Amman, Jordan, Jordan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05592938


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