Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE) (PRESERVE)

May 22, 2026 updated by: University Health Network, Toronto

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Most women affected by breast cancer are treated with breast-conserving surgery to remove the tumour, followed by radiation to reduce the risk of recurrence. Unfortunately, some women will experience recurrence of the cancer in the previously treated breast. These recurrences have historically been treated by removing the whole breast or a second breast-conserving surgery followed by 3 to 5 weeks of radiation. These treatments can negatively impact mental health and quality of life or lead to harmful side effects that could impact the skin, breast, ribs, heart and lungs.

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).

The target population for this study is women with localized recurrent or new primary breast cancer in the previously irradiated breast. This is a prospective single arm phase 2 trial of external beam rPBI using 26Gy in 5 fractions delivered daily over 1-week after a second lumpectomy for LR following prior BCS and adjuvant whole or partial breast irradiation. Using a multi-institutional and international network of comprehensive cancer centers, this study will advance global knowledge of how to optimally treat women with this disease.

Study Type

Interventional

Enrollment (Estimated)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • Keelan Byrne, MD
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 105401
        • Recruiting
        • A.C.Camargo Cancer Center
        • Contact:
        • Principal Investigator:
          • Guilherme Rocha Melo Gondim, MD
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jessica Conway, M.D.
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Science Centre - Verspeeten Family Cancer Centre
        • Contact:
        • Principal Investigator:
          • Joelle Helou, MD
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health
        • Contact:
          • Dr. Medhat El-Mallah, MD
          • Phone Number: 905-576-8711
          • Email: melmallah@lh.ca
        • Contact:
        • Principal Investigator:
          • Dr. Medhat El-Mallah, M.D.
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre
        • Contact:
        • Principal Investigator:
          • Hanbo Chen, MD
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Danielle Rodin, MD
        • Principal Investigator:
          • Anne Koch, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Principal Investigator:
          • Jean-Marc Bourque, MD
        • Contact:
      • Montreal, Quebec, Canada, G1G 5X1
        • Recruiting
        • CHU de Quebec-Universite Laval
        • Contact:
        • Principal Investigator:
          • Valarie Theberge, MD
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
        • Principal Investigator:
          • Michael Yassa, MD
        • Contact:
        • Contact:
          • Phone Number: 514 252-3400
  • Chile
    • Santiago Metropolitan
      • Vitacura, Santiago Metropolitan, Chile, 7630370
        • Recruiting
        • Clinica IRAM
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Valentina Ovalle, M.D.
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Centre
        • Contact:
        • Principal Investigator:
          • Inbal Golomb
  • Italy
      • Florence, Italy
        • Recruiting
        • AOU Careggi - Florence University Hospital
        • Contact:
        • Principal Investigator:
          • Icro Meattini, M.D.
  • Jordan
    • Jordan
      • Amman, Jordan, Jordan
        • Recruiting
        • King Hussein Cancer Centre
        • Contact:
        • Principal Investigator:
          • Fadwa D Abdel Rahman, MD
  • Kenya
      • Nairobi, Kenya
        • Recruiting
        • The Aga Khan University
        • Contact:
        • Principal Investigator:
          • Angela Waweru, FRCR
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Universitiy Malaya Medical Centre
        • Contact:
        • Principal Investigator:
          • Po Lin Ooi, MD
  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Naamit K Gerber, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Eileen Connolly, MD
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • Recruiting
        • Virgina Community University Massey Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Doug Arthur, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years
  • In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
  • Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
  • >5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
  • Clinically node negative
  • Negative margins (no tumour on ink)
  • Recovered from surgery with the incision completely healed and no signs of infection

Exclusion Criteria:

  • Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
  • Tumour histology limited to lobular carcinoma only
  • Extensive intraductal component
  • T4 disease
  • Node positive or distant metastatic disease
  • Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
  • Currently pregnant or lactating
  • Presence of an ipsilateral breast implant or pacemaker
  • Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
  • Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
  • Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
  • Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rPBI
26Gy in 5 daily fractions over 1-week
Radiation: rPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade ≥3 toxicity associated with treatment
Time Frame: During accrual period, up to 3 years
TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
During accrual period, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency radiation-associated toxicity (acute)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (acute)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Frequency radiation-associated toxicity (late)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (late)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence (invasive and DCIS)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Cumulative incidence function will be used to estimate local recurrence with death as a competing risk.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of distant recurrence (invasive and DCIS)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Cumulative incidence function will be used to estimate distant recurrence and distance recurrence with death as a competing risk.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (frequency)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of recurrence will be summarized by frequency.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (percentage)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of recurrence will be summarized by percentage.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (frequency)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of recurrence will be summarized by frequency.
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (percentage)
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of recurrence will be summarized by percentage
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence after rPBI requiring mastectomy
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Cumulative incidence function will be used to estimate local recurrence after rPBI requiring mastectomy with death as a competing risk
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Invasive breast cancer free survival
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Kaplan-Meier method will be used to estimate invasive breast cancer free survival
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Overall survival
Time Frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Kaplan-Meier method will be used to estimate overall survival
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Satisfaction with breasts
Time Frame: Baseline, 1 year, 3 years, and 5 years post rPBI
Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated.
Baseline, 1 year, 3 years, and 5 years post rPBI
Financial toxicity associated with treatment
Time Frame: Baseline, 3 months, 1 year, and 3 years post rPBI
Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated.
Baseline, 3 months, 1 year, and 3 years post rPBI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre
Columbia University
NYU Langone Health
CHU de Quebec-Universite Laval
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Tel-Aviv Sourasky Medical Center
Aga Khan University
Virginia Commonwealth University
London Health Sciences Centre
Maisonneuve-Rosemont Hospital
Peter MacCallum Cancer Centre, Australia
AC Camargo Cancer Center
King Hussein Cancer Center
Royal Victoria Regional Health Centre
University Malaysia Medical Centre
Lakeridge Health
AOU Careggi
Clínica IRAM

Investigators

  • Principal Investigator: Danielle Rodin, MD, Princess Margaret Cancer Centre
  • Principal Investigator: Anne Koch, MD, Princess Margaret Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Estimated)

June 27, 2027

Study Completion (Estimated)

June 27, 2027

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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