Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
University Health Network, Toronto
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).
Description
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 sur…
Eligibility
- Age range
- 18–99 years
- Sex
- Female
- Healthy volunteers
- No
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 breas…
Interventions
- RadiationrPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Locations (17)
- NYU Langone HealthNew York, New York
- Columbia University Medical CenterNew York, New York
- Virgina Community University Massey Comprehensive Cancer CenterRichmond, Virginia
- Peter MacCallum Cancer CentreMelbourne, Victoria
- A.C.Camargo Cancer CenterSão Paulo, São Paulo
- Royal Victoria Regional Health CentreBarrie, Ontario