Short-Course Radiation Therapy for Breast Cancer

(PRESERVE Trial)

Recruiting at 14 trial locations

Overseen By Anne Koch, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Multicentric disease, Lobular carcinoma, Node positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

171 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a shorter, one-week radiation therapy, known as rPBI or Partial Breast Irradiation, for women with early-stage breast cancer who have had prior radiation. The goal is to determine if this shorter schedule is as safe and effective as longer treatments, with fewer side effects and better cosmetic results. It targets women who have undergone breast-conserving surgery for a new or recurring small breast tumor and received breast radiation over five years ago.

As an unphased trial, this study provides an opportunity to explore innovative treatment options that could enhance quality of life.

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 prior data suggests that this radiation therapy technique is safe for breast cancer patients?

Research has shown that partial breast irradiation (rPBI) is a safe option for women who have previously received whole breast radiation. It tends to cause fewer side effects and offers better cosmetic results compared to traditional methods. Studies indicate that after breast-conserving surgery, rPBI can serve as a safe alternative to more invasive procedures like mastectomy.

In one study with a 3-year follow-up, only 3.5% of patients experienced noticeable cosmetic changes, and the treatment was generally well-tolerated. Another study involving 276 breast cancer patients found that a 1-week, more intense radiation schedule led to manageable side effects. Most patients handled the treatment well, with few serious side effects reported.

This evidence suggests that rPBI is a well-tolerated option for many women, with the potential for fewer side effects and better cosmetic outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard breast cancer treatments that often involve several weeks of radiation therapy, rPBI offers a unique approach by delivering 26Gy of radiation in just five daily sessions over one week. Researchers are excited about this treatment because it significantly reduces the treatment duration, potentially making it more convenient for patients without compromising effectiveness. This short-course therapy could lead to fewer side effects and improve the quality of life for patients, making it a promising alternative to traditional long-course radiation therapies.

What evidence suggests that this ultra-hypofractionated rPBI regimen could be effective for breast cancer?

Studies have shown that partial breast irradiation (rPBI), which participants in this trial will receive, can reduce the chance of breast cancer returning by 16% over 10 years. This treatment also improves breast cancer survival rates by 4% over 15 years. Research suggests that rPBI is safer than more invasive surgeries like mastectomy, particularly for those who have previously undergone radiation. It typically causes less damage to nearby healthy tissue, leading to fewer side effects and better cosmetic outcomes. With shorter treatment times, this method offers convenience and has effectively maintained positive results for patients with early-stage breast cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Danielle Rodin, MD

Principal Investigator

Princess Margaret Cancer Centre

Anne Koch, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• rPBI

Trial Overview 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.

How Is the Trial Designed?

Group I: rPBI Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

CHU de Quebec (Université Laval)

Collaborator

Trials

1

Recruited

170+

l'Hopital Maisonneuve-Rosemont

Collaborator

Trials

1

Recruited

170+

L'Institut de recherche du Centre universitaire de sante McGill

Collaborator

Trials

1

Recruited

170+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

Florence University Hospital

Collaborator

Tel-Aviv Sourasky Medical Center

Collaborator

Trials

584

Recruited

331,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Partial breast irradiation (PBI) and ultra-hypofractionated whole breast irradiation (uWBI) are effective alternatives to traditional radiation therapy, reducing treatment time from 3-6 weeks to just 1-2 weeks for select patients, which enhances convenience and access to care.

Recent long-term studies indicate that PBI and accelerated PBI (APBI) are safe and effective for low-risk patients with specific breast cancer characteristics, showing similar or improved outcomes in local recurrence and toxicity compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern radiation techniques in early stage breast cancer for the breast radiologist. Jones, BM., Green, S.[2021]

In a study of 158 patients undergoing weekly hypofractionated breast irradiation (WHBI) after breast-conserving surgery, the rate of ipsilateral breast tumor recurrence was very low at 1.3%, indicating strong efficacy in preventing local cancer recurrence.

The 3-year disease-free survival rate was 97.5%, and the overall survival rate was 96.2%, with most patients experiencing only mild acute toxicities, suggesting that WHBI is a safe and effective treatment option for early-stage breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. Dragun, AE., Ajkay, NJ., Riley, EC., et al.[2018]

In a study of 157 older patients with low-risk breast cancer, both accelerated partial breast irradiation (APBI) and ultra-APBI (uAPBI) showed similar oncologic outcomes, with no significant differences in local or regional recurrence rates, disease-free survival, or overall survival.

Late toxicity and cosmetic results were also comparable between the two treatment methods, suggesting that uAPBI, which uses a single fraction of brachytherapy, is a safe and effective option for reducing treatment intensity in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

APBI Versus Ultra-APBI in the Elderly With Low-Risk Breast Cancer: A Comparative Analysis of Oncological Outcome and Late Toxicity. Hannoun-Lévi, JM., Montagne, L., Sumodhee, S., et al.[2021]

The UK-FAST-Forward study indicated that ultra-hypofractionated whole-breast irradiation (ultra-HF-WBI) is not inferior to traditional high-fractionated whole-breast irradiation, but safety concerns have prevented its use in Japan.

A new phase II trial involving 98 patients aims to assess the safety of ultra-HF-WBI after breast-conserving surgery, focusing on the occurrence of late adverse events over 3 years, which could influence future treatment guidelines in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Mitsuyoshi, T., Ono, Y., Ashida, R., et al.[2023]

Accelerated partial breast irradiation (APBI) is an advanced form of hypofractionated external beam radiation therapy (HERT) that allows for faster treatment due to targeting a smaller area, which may improve patient convenience and comfort.

Both APBI and HERT are currently being tested in randomized trials, highlighting their potential as effective treatment options for breast cancer, although they are still considered investigational.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an advanced form of hypofractionation. Budrukkar, A.[2019]

In a study involving 396 patients treated with ultra-hypofractionated breast radiotherapy, the five-year local-relapse free survival (LRFS) rate was an impressive 98.8%, indicating high efficacy in controlling breast cancer.

While ultra-hypofractionated radiotherapy showed excellent tumor control, certain regimens, particularly the 5.7 Gy weekly fraction and tumor bed boost, were linked to a higher risk of acute and late skin toxicities, highlighting the need for careful treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. Sauvage, LM., Loap, P., Vu-Bezin, J., et al.[2023]

Hypofractionated whole breast irradiation (WBI) has been shown to produce outcomes comparable to conventional radiation in early-stage breast cancer patients, suggesting it is a safe and effective treatment option.

Current trials, including a phase III study by the Radiation Therapy Oncology Group, are investigating the feasibility and effectiveness of adding a concurrent tumor bed boost to hypofractionated WBI, which may enhance treatment outcomes and broaden its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated fractionation with a concurrent boost for early stage breast cancer. Freedman, GM., White, JR., Arthur, DW., et al.[2022]

Hypofractionated radiation therapy, which delivers fewer but larger doses of radiation over a shorter period, has shown comparable outcomes to conventional radiation in treating breast cancer, suggesting it could be an effective alternative.

Ongoing phase 3 trials are investigating hypofractionated whole breast irradiation and accelerated partial breast irradiation, which may lead to broader acceptance of these methods for early-stage breast cancer, although concerns about patient selection and late toxicity remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Freedman, GM.[2021]

In a phase II trial involving 73 early-stage breast cancer patients, the external beam partial breast irradiation (PBI) regimen of 35 Gy in 7 daily fractions was found to be well-tolerated, with no Grade 3 toxicity reported and only minor side effects observed.

The treatment demonstrated high efficacy, achieving a 98% local control rate and a 96.7% rate of freedom from distant metastases over a median follow-up of 40 months, indicating it is a safe and effective option for patients aged 60 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seven fractions to deliver partial breast irradiation: the toxicity is Low. Trovo, M., Avanzo, M., Vinante, L., et al.[2018]

Adopting hypofractionated whole breast irradiation and accelerated partial breast irradiation (APBI) can lead to improved survival rates and a higher likelihood of remaining disease-free for women undergoing breast cancer treatment, with a 4% increase in survival and a 7% increase in disease-free status at 15 years compared to conventional schedules.

In women who had lumpectomies, the hypofractionation model showed a 62% chance of remaining alive with an intact breast, compared to 54% in the conventional model, highlighting the potential benefits of shorter radiation schedules in improving patient outcomes in emerging economies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nation-Scale Adoption of Shorter Breast Radiation Therapy Schedules Can Increase Survival in Resource Constrained Economies: Results From a Markov Chain Analysis. Khan, AJ., Rafique, R., Zafar, W., et al.[2018]

Recent studies support the use of shorter radiotherapy courses for early-stage breast cancer, with ultra-hypofractionated regimens allowing treatment in as few as 5 sessions, which can reduce the burden on patients.

Breast cancer is increasingly recognized as a low alpha-beta ratio malignancy, suggesting that larger doses per fraction may be more effective, leading to a shift towards hypofractionated and ultra-hypofractionated treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-stage Breast Cancer: Tailored External Beam Fractionation Approaches for Treatment of the Whole or Partial Breast. Prionas, ND., Stephens, SJ., Blitzblau, RC.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12364632/

Impact on outcomes of ultra hypofractionation or ... Overall, it reduced the risk of recurrence by 16% at 10 years and breast cancer-specific survival by 4% at 15 years. Different groups exhibit ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05592938

NCT05592938 | Partial Breast Re-irradiation Using Ultra ... Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06272

Partial Breast Re-irradiation Using Ultra Hypofractionation ... By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early- ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK589138/

Executive Summary - Partial Breast Irradiation for Breast Cancer IMRT compared with WBI showed no difference in IBR and overall survival at 5 and 10 years (low SOE) and better patient-rated cosmesis at 10 years (low SOE).

5. nature.com nature.com/articles/s41598-025-88600-5

Hypofractionated partial breast irradiation after ... The median follow-up was 66.3 (range: 42.0-105.4) months. The 3-year overall cosmetic deterioration rate was 3.5%. The rates of grade 2 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955656/

Ultra-hypofractionated one-week locoregional radiotherapy ... We present acute toxicity outcomes in 276 breast cancer patients receiving 1-week UHF therapy to the breast/chest wall with RNI, with or without IMN ...