| Protocol No: | ECCT/25/09/03 | Date of Protocol: | 21-06-2024 |
| Study Title: | Partial breast re-irradiation using ultra hypofractionation (PRESERVE) Phase 2 multi-institutional study |
| Study Objectives: | Primary Objective is: To evaluate the risk of adverse events (AEs) of breast re-irradiation at 1-year with a 1-week repeat partial breast irradiation (rPBI) regimen following breast-conserving surgery (BCS) as treatment for localized, recurrent or new primary breast cancer (LR) in the previously irradiated breast Secondary Objectives are: 1. To determine the toxicity associated with treatment 2. To determine the risk of local, regional, and distant recurrence 3. To determine the location of local recurrence (in-field or out-of-field) 4. To determine the financial toxicity associated with treatment 5. To determine the patient-reported quality of life associated with treatment 6. To measure invasive breast cancer free survival, mastectomy free survival, and overall survival |
| Laymans Summary: | The purpose of this study is to test the good and bad effects of a shorter 1-week radiotherapy schedule called hypofractionated radiation therapy, in participants with breast cancer recurrence after prior treatment with surgery and radiation therapy. Hypofractionation, in which radiation is given using a larger dose per day over a shorter period, is now routinely used to treat women with a new diagnosis of breast cancer and with no prior history of radiation, who require radiation to the breast after surgery. Clinical trials have shown that hypofractionated radiation delivered over 5 treatments (1 week) has fewer early side effects, improved convenience, and equivalent rates of breast cancer recurrence and late side effects from treatment, compared to longer courses of treatment. However, this 1-week hypofractionated radiation schedule has not yet been used in women with recurrent disease. This radiotherapy schedule could control your cancer, but it could also cause side effects, which are described in the risks section below. The study doctors hope to learn if this shorter radiation schedule has comparable effectiveness and lesser side effects than longer radiation schedules. There will be about 171 people taking part in this study.
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| Abstract of Study: | Breast cancer is the leading cause of cancer in women worldwide, with over 2 million cases diagnosed every year. (1) Although advances in treatment have led to an overall reduction in breast cancer mortality (2), survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. (3) Fear of mastectomy has also been associated with delays in seeking appropriate and timely management of disease. (4) As a result, there is increasing interest to identify treatment options that include breast preservation. 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 (WBI). (5,6) By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes compared to repeat WBI. However, previously published studies have used long fractionation regimens for rPBI delivered over 3 to 5 weeks, with up to 30 fractions, which can present a challenge for both patients and health systems. (5,6) This is particularly true in low- and middle-income countries, where more than half of new breast cancer cases now occur. 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. (7,8) These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. We hypothesize that a 1-week ultrahypofractionated 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). 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. (9-12). |