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Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE) for Recurrent Breast Cancer

This study is testing a new way to treat breast cancer that has come back in the same breast after previous radiation. It's called external beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions, delivered over one week. This treatment aims to reduce side effects and improve cosmetic results compared to other options like mastectomy (removing the whole breast) or longer radiation courses. You might be able to join if you are a woman over 18, have an in-breast recurrence or new primary tumor less than 3.0 cm, and it's been more than 5 years since your last breast radiation. The main goal is to see how many participants experience severe side effects (Grade ≥3 toxicity) from the treatment. The study is planning to enroll 171 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 171 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-related side effects for up to 3 years after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05592938

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)

Recruiting
NAAges 18–99InterventionalTreatment
University Health Network, Toronto
~171 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:rPBI

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade ≥3 toxicity associated with treatment
Measured over During accrual period, up to 3 years

Conditions

Breast Cancer
Breast Cancer Recurrent

Explore related trials

Breast Carcinoma

Where it's being run

19 sites across 12 states
Ontario5
Quebec3
New York2
Virginia1
Victoria1
São Paulo1
Santiago Metropolitan1
Israel1

Study leadership

  • Danielle Rodin, MD · PRINCIPAL_INVESTIGATOR · Princess Margaret Cancer Centre
  • Anne Koch, MD · PRINCIPAL_INVESTIGATOR · Princess Margaret Cancer Centre

Who to contact

Danielle Rodin, MD
[email protected]
(416) 946-6513
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Grade ≥3 toxicity associated with treatmentDuring 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.