About this trial
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 (3 toxicity).
The target population for this study is women with localised 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.
Patient Profile
Women with localised recurrent or new primary breast cancer in the previously irradiated breast
Where’s this trial being run?
Cork University Hospital, St Luke’s Radiation Oncology Network @ Beaumont Hospital, St Luke’s Radiation Oncology Network @ St James’s Hospital, St Luke’s Radiation Oncology Network @ St Luke’s Hospital, and University Hospital Galway
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | PRESERVE (Breast) |
|---|---|
| Number: | 24-35 |
| Full Title: | Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE) |
| Principal Investigator: | Prof Aisling Barry (CUH), Prof Frances Duane (SLRON), Prof Joseph Martin (UHG) |
|---|---|
| Type: | Collaborative |
| Sponsor: | University Health Network (Global), Cancer Trials Ireland (local in ROI) |
| Recruitment Started: |
Global: June 2023 Ireland: Sept 2026 |
| Global Recruitment Target: | 171 |
|---|---|
| Ireland Recruitment Target: | 3 |