Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

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).

Conditions

• Breast Cancer
• Breast Cancer Recurrent

Interventions

RADIATION

rPBI

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Royal Victoria Regional Health Centre

  collaborator UNKNOWN

• AC Camargo Cancer Center

  collaborator OTHER

• King Hussein Cancer Center

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• Peter MacCallum Cancer Centre, Australia

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Tel-Aviv Sourasky Medical Center

  collaborator OTHER_GOV

• Virginia Commonwealth University

  collaborator OTHER

• AOU Careggi

  collaborator UNKNOWN

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Maisonneuve-Rosemont Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Lakeridge Health

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• Clínica IRAM

  collaborator UNKNOWN

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Danielle Rodin, MD · Princess Margaret Cancer Centre

• Anne Koch, MD · Princess Margaret Cancer Centre

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-27

Primary Completion

2027-06-27

Completion

2027-06-27

Countries

• United States
• Australia
• Brazil
• Canada
• Chile
• Israel
• Italy
• Jordan

Study Locations