Short-Course Radiation Therapy for Breast Cancer
(PRESERVE Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Multicentric disease, Lobular carcinoma, Node positive, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment rPBI, Partial Breast Irradiation, rPBI, Ultra Hypofractionation for breast cancer?
Recent studies show that partial breast irradiation (PBI) and ultra-hypofractionated radiation are effective and safe for certain breast cancer patients, offering similar or better outcomes compared to traditional methods, with fewer side effects and shorter treatment times.
12345Is short-course radiation therapy for breast cancer safe?
Research shows that short-course radiation therapy, including ultra-hypofractionation and partial breast irradiation, is generally safe for breast cancer patients. Studies have demonstrated low toxicity and good tolerance, making it a safe option for suitable patients.
16789How does the treatment rPBI differ from other breast cancer treatments?
The treatment rPBI (Partial Breast Irradiation) is unique because it focuses radiation only on the part of the breast where the tumor was, rather than the whole breast, and it uses a shorter treatment schedule of 1-2 weeks instead of the usual 3-6 weeks. This makes it more convenient and potentially less costly for patients, while still being effective and safe for those with early-stage breast cancer.
1271011Eligibility Criteria
This trial is for women over 18 with early-stage breast cancer who've had prior radiation and surgery, are clinically node negative, have a tumor under 3.0 cm without distant metastases or severe late skin toxicity from previous treatments. It excludes those with multifocal disease, implants or pacemakers near the chest, recent chemotherapy, certain psychiatric disorders, specific non-malignant diseases, or current pregnancy.Inclusion Criteria
My cancer has not spread to my lymph nodes.
It has been over a year since I finished breast radiotherapy.
I am older than 18 years.
+5 more
Exclusion Criteria
I do not have serious heart, lung, lupus, or scleroderma diseases that would prevent radiation treatment.
Currently pregnant or lactating
I couldn't start radiation within the required time after my breast surgery or chemotherapy.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 26Gy in 5 daily fractions over 1-week of re-irradiation with partial breast irradiation (rPBI) following breast-conserving surgery
1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of toxicity and quality of life
5 years
Participant Groups
The PRESERVE trial tests a shorter course of re-irradiation called rPBI (26 Gray in 5 daily fractions over one week) after breast-conserving surgery to see if it's safe and effective as an alternative to mastectomy for women who previously received whole breast radiation.
1Treatment groups
Experimental Treatment
Group I: rPBIExperimental Treatment1 Intervention
26Gy in 5 daily fractions over 1-week
rPBI is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as Partial Breast Irradiation for:
- Early-stage breast cancer
- Re-irradiation after prior whole breast radiation
🇺🇸 Approved in United States as rPBI for:
- Early-stage breast cancer
- Re-irradiation after prior whole breast radiation
🇯🇵 Approved in Japan as Ultra Hypofractionation for:
- Early-stage breast cancer
- Node-negative tumors not requiring boost irradiation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
Odette Cancer CentreToronto, Canada
CHU de Québec-Université LavalMontreal, Canada
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-MontréalMontreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
CHU de Quebec (Université Laval)Collaborator
l'Hopital Maisonneuve-RosemontCollaborator
L'Institut de recherche du Centre universitaire de sante McGillCollaborator
NYU Langone HealthCollaborator
Centre hospitalier de l'Université de Montréal (CHUM)Collaborator
Peter MacCallum Cancer Centre, AustraliaCollaborator
Sunnybrook Health Sciences CentreCollaborator
Royal Victoria Regional Health CentreCollaborator
AC Camargo Cancer CenterCollaborator
References
Modern radiation techniques in early stage breast cancer for the breast radiologist. [2021]Partial breast irradiation (PBI) and ultra-hypofractionated whole breast irradiation (uWBI) are contemporary alternatives to conventional and standard hypofractionated whole breast irradiation (WBI), which shorten treatment from 3 to 6 weeks to 1-2 weeks for select patients. PBI and accelerated PBI (APBI) can be delivered with external beam radiation (3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT)), intraoperative radiation (IORT), or brachytherapy. These new radiation techniques offer the advantage of convenience and lower cost, which ultimately improves access to care. Globally, the COVID 19 pandemic has accelerated APBI/PBI and ultra-hypofractionated regimens into routine practice for carefully selected patients. Recent long-term data from randomized controlled trials (RCTs) have demonstrated these techniques are safe and effective in suitable patients demonstrating equivalent or improved local recurrence, acute/late toxicity, and cosmesis. PBI and APBI should be limited to low risk unifocal invasive ductal carcinoma and ductal carcinoma in situ with tumor size
Accelerated partial breast irradiation: an advanced form of hypofractionation. [2019]Altered fractionation schedules are being increasingly investigated in the treatment of breast cancer. Two such schedules that are frequently compared are hypofractionated external beam radiation therapy (HERT) and accelerated partial breast irradiation (APBI). Though these two modalities are considered separately, APBI is an actually an advanced form of hypofractionation, where acceleration of the treatment is possible due to the smaller volume being irradiated. HERT as well as APBI are investigational at present and are being tested in randomized trials. This article looks at the advantages of APBI as a hypofractionation schedule.
Nation-Scale Adoption of Shorter Breast Radiation Therapy Schedules Can Increase Survival in Resource Constrained Economies: Results From a Markov Chain Analysis. [2018]Hypofractionated whole breast irradiation and accelerated partial breast irradiation (APBI) offer women options for shorter courses of breast radiation therapy. The impact of these shorter schedules on the breast cancer populations of emerging economies with limited radiation therapy resources is unknown. We hypothesized that adoption of these schedules would improve throughput in the system and, by allowing more women access to life-saving treatments, improve patient survival within the system.
Early-stage Breast Cancer: Tailored External Beam Fractionation Approaches for Treatment of the Whole or Partial Breast. [2022]Historically, radiotherapy fractionation for early-stage breast cancer primarily consisted of 1.8-2 Gy per fraction given once daily to a total dose of 45-66 Gy over 5-7 weeks for whole breast treatment. Partial breast treatment employed larger dose per fraction (3.4-3.85 Gy) in 10 fractions given twice daily over 1 week. Radiobiologically, breast cancer is increasingly appreciated as a low alpha-beta ratio malignancy that is best treated with larger dose per fraction. Over the past 10 years, there have been increasing data from multiple large randomized clinical trials that support the use of shorter treatment courses: first hypofractionated regimens consisting of 15-20 treatments, and more recently, ultra-hypofractionated regimens as short as 5 treatments. Simultaneously, data from modern partial breast irradiation (PBI) trials support once daily treatment regimens ranging from 1-5 treatments. Shorter treatment courses represent less treatment burden on patients, reduced financial impact, and potentially improved access to care for patients with transportation and/or socioeconomic barriers. Here we review the evolution of whole and partial breast treatment regimens for early-stage breast cancer.
First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. [2018]To report early outcome analysis of a prospective institutional phase 2 trial of weekly hypofractionated breast irradiation (WHBI) for patients undergoing breast-conserving surgery (BCS).
APBI Versus Ultra-APBI in the Elderly With Low-Risk Breast Cancer: A Comparative Analysis of Oncological Outcome and Late Toxicity. [2021]Accelerated partial breast irradiation (APBI) represents a validated technique for low-risk breast cancer. Recently, ultra-APBI (uAPBI) using fewer than 5 fractions was described in the literature. We compared clinical outcomes and late toxicity after APBI or uAPBI in older patients.
Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. [2023]Ultra-hypofractionation breast radiotherapy is a safe alternative to moderate hypofractionation. This study reports the results of two ultrahypofractionated regimens used in clinical practice in a high-volume radiotherapy center in terms of efficacy and of tolerance.
Multi-institutional phase II study of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for breast cancer in Japan: Kyoto Radiation Oncology Study Group (UPBEAT study). [2023]The UK-FAST-Forward study showed that ultra-hypofractionated whole-breast irradiation (ultra-HF-WBI) involving five fractions of 26 Gy radiation over 1 week was not inferior to HF-WBI. However, it is not used in Japan due to safety concerns. In April 2022, we commenced a multi-institutional, single-arm, phase II trial. Our aim is to confirm the safety of ultra-HF-WBI after breast-conserving surgery (BCS) for breast cancer in Japanese women.
Seven fractions to deliver partial breast irradiation: the toxicity is Low. [2018]To assess toxicity and clinical outcome, in breast cancer patients treated with external beam partial breast irradiation (PBI) consisting of 35 Gy in 7 daily fractions (5 Gy/fraction).
Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]Hypofractionated radiation refers to the use of fewer, larger-dose radiation treatments that are usually given over a shorter time period compared to conventional radiation fraction sizes. Randomized trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation. For a higher-risk population for local recurrence, a phase 3 trial by the Radiation Therapy Oncology Group (RTOG) is currently studying hypofractionated WBI with a concurrent tumor bed boost over 3 weeks. Accelerated partial breast irradiation limits radiation to the region of the tumor bed for 1-3 weeks and is the subject of an ongoing randomized trial by the National Surgical Breast and Bowel Project and RTOG. Questions remain for hypofractionation about optimal patient selection, radiation techniques, and the risk of late toxicity. But results from current trials could make hypofractionation more widely accepted for patients with early-stage breast cancer.
Accelerated fractionation with a concurrent boost for early stage breast cancer. [2022]Hypofractionated radiation refers to treatment with greater than 2 Gy per fraction, usually in fewer number and an overall shorter treatment period, compared to conventional radiation fractionation. Randomized prospective trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation in early stage postlumpectomy radiation in selected groups of patients. These data have changed the traditional radiobiology estimation of the alpha/beta ratio that predicted fractionation sensitivity for breast cancer, suggesting that further increase in dose per fraction is possible for early stage breast cancer without significantly increasing late effects. Many questions remain regarding hypofractionated WBI and span from optimal patient selection to radiation technique including dose planning optimization and the incorporation of a tumor bed boost. A concurrent radiation boost has been studied in a number of single institution studies and has shown to be feasible with acceptable acute and short-term late toxicity. A phase III trial by the Radiation Therapy Oncology Group (RTOG 1005) in North America and other trials in Europe are currently studying in-breast cancer control from hypofractionated WBI with a concurrent tumor bed boost. Results from these current trials could improve the acceptance and broaden the applicability of hypofractionation treatment courses for the treatment of patients with early stage breast cancer.