Re-irradiation for breast cancer using a short radiation course

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of partial breast re-irradiation (rPBI) using an ultra-hypofractionated approach for women who have experienced a recurrence of breast cancer after previous radiation treatment. The study aims to provide a shorter, more convenient 1-week radiation regimen following breast-conserving surgery, which is hypothesized to result in lower toxicity and improved cosmetic outcomes compared to traditional longer radiation schedules. Participants will be monitored for toxicity levels and overall treatment effectiveness over a year.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Columbia University Medical Center
  New York, New York, United States Recruiting
• Virgina Community University Massey Comprehensive Cancer Center
  Richmond, Virginia, United States Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• A.C.Camargo Cancer Center
  São Paulo, São Paulo, Brazil Recruiting
• Royal Victoria Regional Health Centre
  Barrie, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Danielle Rodin, MD — Princess Margaret Cancer Centre
• Study coordinator: Danielle Rodin, MD
• Email: danielle.rodin@uhn.ca
• Phone: (416) 946-6513

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.