Recruiting

PRESERVEPartial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Sponsor:

University Health Network, Toronto

Code:

NCT05592938

Conditions

Breast Cancer

Breast Cancer Recurrent

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

rPBI

Study Details

Brief 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

Study ID

NCT05592938

Start date

Jun 27, 2023

Status verified date

Jul, 2026

Completion date

Jun 27, 2027

Anticipated

Primary completion date

Jun 27, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
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
Current or prior diagnosis of bilateral breast cancer

Study Design

Enrollment

171 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rPBI

26Gy in 5 daily fractions over 1-week

Interventions

rPBI

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

Primary outcome measure

Grade ≥3 toxicity associated with treatment [ Time Frame: During accrual period, up to 3 years ]

Central Contacts and Locations

Central contacts

Danielle Rodin, MD

(416) 946-6513 danielle.rodin@uhn.ca

Anne Koch, MD

(416) 946-2919 anne.koch@uhn.ca

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Naamit K Gerber, MD

212-731-5304 naamit.gerber@nyulangone.org

Principal Investigator:

Naamit K Gerber, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Eileen Connolly, MD

646-317-4244 epc2116@cumc.columbia.edu

Principal Investigator:

Eileen Connolly, MD

Virgina Community University Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298-0037

Contacts

Doug Arthur, M.D.

804.828.0539 douglas.arthur@vcuhealth.org

Principal Investigator:

Doug Arthur, M.D.

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Jessica Conway, M.D.

(705) 728-9090 conwayj@rvh.on.ca

Christiaan Stevens, M.D.

(705) 728-9090 stevensc@rvh.on.ca

Principal Investigator:

Jessica Conway, M.D.

London Health Science Centre - Verspeeten Family Cancer Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Joelle Helou, MD

(519) 685-8500 Ext. 53672 joelle.helou@lhsc.on.ca

Principal Investigator:

Joelle Helou, MD

Lakeridge Health

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Dr. Medhat El-Mallah, MD

905-576-8711 melmallah@lh.ca

Ashane Somasiri, BSc

905-576-8711 asomasiri@lh.ca

Principal Investigator:

Dr. Medhat El-Mallah, M.D.

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Hanbo Chen, MD

416-480-5000 hanbo.chen@sunnybrook.ca

Principal Investigator:

Hanbo Chen, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Danielle Rodin, MD

danielle.rodin@uhn.ca

Principal Investigator:

Danielle Rodin, MD

CHU de Québec-Université Laval

Recruiting

Montreal, Quebec, Canada, G1G 5X1

Contacts

Valarie Theberge, MD

(418) 525-4444 valerie.theberge.med@ssss.gouv.qc.ca

Principal Investigator:

Valarie Theberge, MD

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

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Michael Yassa, MD

michael.yassa.med@ssss.gouv.qc.ca

514 252-3400

Principal Investigator:

Michael Yassa, MD

Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Jean-Marc Bourque, MD

514-890-8254 jean-marc.bourque.med@ssss.gouv.qc.ca

Principal Investigator:

Jean-Marc Bourque, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

Hypofractionated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-17.