Re-irradiation for breast cancer using a short radiation course
Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
This study is testing a shorter, one-week radiation treatment for women with recurring breast cancer to see if it is safer and leads to better results than the usual longer treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 171 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 17 sites (New York, New York and 16 other locations) |
| Trial ID | NCT05592938 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with in-breast recurrence or new primary breast cancer, having tumors less than 3.0 cm and at least 5 years since their last radiation treatment.
Not a fit: Patients with multicentric disease, node-positive or metastatic disease, or serious non-malignant conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less toxic and more convenient treatment option for women with recurrent breast cancer.
How similar studies have performed: Other studies have shown promise with similar hypofractionated approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 16 other locations
- 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)
- London Health Science Centre - Verspeeten Family Cancer Centre — London, Ontario, Canada (Recruiting)
- Lakeridge Health — Oshawa, Ontario, Canada (Recruiting)
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- CHU de Québec-Université Laval — Montreal, Quebec, Canada (Recruiting)
- Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal, Quebec, Canada (Recruiting)
- Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
- Clinica IRAM — Vitacura, Santiago Metropolitan, Chile (Recruiting)
- Tel-Aviv Sourasky Medical Centre — Tel Aviv, Israel (Recruiting)
- AOU Careggi - Florence University Hospital — Florence, Italy (Recruiting)
- King Hussein Cancer Centre — Amman, Jordan, Jordan (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.