Breast CancerPRESERVENCT05592938
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
A study testing rPBI in people with Breast Cancer and Breast Cancer Recurrent, run by University Health Network, Toronto at 19 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Recurrent
- What is being tested?
- rPBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 19 sitesin 10 countries
- Study dates
- 27 Jun 2023to 27 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
- Tumour histology limited to lobular carcinoma only
- T4 disease
- Node positive or distant metastatic disease
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
- Currently pregnant or lactating
Show all 12Show fewer
- Presence of an ipsilateral breast implant or pacemaker
- Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
- Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
- Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
- Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0
- Current or prior diagnosis of bilateral breast cancer
Trial locations and contacts
19 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 10 countries
Canada8 sites, 8 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Jessica Conway, M.D., (705) 728-9090, conwayj@rvh.on.ca
Christiaan Stevens, M.D., (705) 728-9090, stevensc@rvh.on.ca
- Recruiting
London Health Science Centre - Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
Joelle Helou, MD, (519) 685-8500 Ext. 53672, joelle.helou@lhsc.on.ca
Joelle Helou, MD
- Recruiting
CHU de Québec-Université Laval
Montreal, Quebec, G1G 5X1
Valarie Theberge, MD, (418) 525-4444, valerie.theberge.med@ssss.gouv.qc.ca
Valarie Theberge, MD
- Recruiting
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Michael Yassa, MD, michael.yassa.med@ssss.gouv.qc.ca
514 252-3400
- Recruiting
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Jean-Marc Bourque, MD, 514-890-8254, jean-marc.bourque.med@ssss.gouv.qc.ca
Jean-Marc Bourque, MD
- Recruiting
Lakeridge Health
Oshawa, Ontario, L1G 2B9
Dr. Medhat El-Mallah, MD, 905-576-8711, melmallah@lh.ca
Ashane Somasiri, BSc, 905-576-8711, asomasiri@lh.ca
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Hanbo Chen, MD, 416-480-5000, hanbo.chen@sunnybrook.ca
Hanbo Chen, MD
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2C4
Danielle Rodin, MD, danielle.rodin@uhn.ca
Danielle Rodin, MD
United States3 sites, 3 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Naamit K Gerber, MD, 212-731-5304, naamit.gerber@nyulangone.org
Naamit K Gerber, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Eileen Connolly, MD, 646-317-4244, epc2116@cumc.columbia.edu
Eileen Connolly, MD
- Recruiting
Virgina Community University Massey Comprehensive Cancer Center
Richmond, Virginia, 23298-0037
Doug Arthur, M.D., 804.828.0539, douglas.arthur@vcuhealth.org
Doug Arthur, M.D.
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Keelan Byrne, MD, 61 3 8559 8635, keelan.byrne@petermac.org
Keelan Byrne, MD
Brazil1 site, 1 recruiting
- Recruiting
A.C.Camargo Cancer Center
São Paulo, São Paulo, 105401
Guilherme Rocha Melo Gondim, MD, 55 (11) 2189-5010, guilherme.gondim@accamargo.org.br
Guilherme Rocha Melo Gondim, MD
Chile1 site, 1 recruiting
- Recruiting
Clinica IRAM
Vitacura, Santiago Metropolitan, 7630370
Dr. Valentina Ovalle, M.D., +56 2 2754 1700, valentina.ovalle@iram.cl
Jennyfer Cabrera, +562 2754 1700, jennyfer.cabrera@iram.cl
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Centre
Tel Aviv
Inbal Golomb, M.D., 03-6972805, inbalgo@tlvmc.gov.il
Inbal Golomb
Italy1 site, 1 recruiting
- Recruiting
AOU Careggi - Florence University Hospital
Florence
Icro Meattini, M.D., +39 055 2751829, icro.meattini@unifi.it
Icro Meattini, M.D.
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Centre
Amman, Jordan
Fadwa D Abdel Rahman, MD, (962) 6 5300460 ext. 7936, faelrahman@khcc.jo
Fadwa D Abdel Rahman, MD
Kenya1 site, 1 recruiting
- Recruiting
The Aga Khan University
Nairobi
Angela Waweru, FRCR, +254 111 011888, angela.waweru@aku.edu
Angela Waweru, FRCR
Malaysia1 site, 1 recruiting
- Recruiting
Universitiy Malaya Medical Centre
Kuala Lumpur
Po Lin Ooi, MD, +60 3-7949 4422, ooipl@um.edu.my
Po Lin Ooi, MD
About this study
Official title: Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
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).
Read the detailed 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 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).
The target population for this study is women with localized 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.
- Conditions
- Breast Cancer, Breast Cancer Recurrent
- Being tested
- rPBI
- Keywords
- Hypofractionated
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPBIRadiation
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
| Study group | Role | What they receive |
|---|---|---|
| rPBI | Experimental | 26Gy in 5 daily fractions over 1-week Receives: Radiation: rPBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade ≥3 toxicity associated with treatment
TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Measured: During accrual period, up to 3 years
Secondary outcomes (15)
Frequency radiation-associated toxicity (acute)
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (acute)
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Frequency radiation-associated toxicity (late)
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (late)
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence (invasive and DCIS)
Cumulative incidence function will be used to estimate local recurrence with death as a competing risk.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of distant recurrence (invasive and DCIS)
Cumulative incidence function will be used to estimate distant recurrence and distance recurrence with death as a competing risk.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (frequency)
Location of recurrence will be summarized by frequency.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (percentage)
Location of recurrence will be summarized by percentage.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (frequency)
Location of recurrence will be summarized by frequency.
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (percentage)
Location of recurrence will be summarized by percentage
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence after rPBI requiring mastectomy
Cumulative incidence function will be used to estimate local recurrence after rPBI requiring mastectomy with death as a competing risk
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Invasive breast cancer free survival
Kaplan-Meier method will be used to estimate invasive breast cancer free survival
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Overall survival
Kaplan-Meier method will be used to estimate overall survival
Measured: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Satisfaction with breasts
Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated.
Measured: Baseline, 1 year, 3 years, and 5 years post rPBI
Financial toxicity associated with treatment
Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated.
Measured: Baseline, 3 months, 1 year, and 3 years post rPBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start27 Jun 2023
- Primary completion27 Jun 2027 (estimated)
- Study completion27 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Royal Victoria Regional Health Centre, AC Camargo Cancer Center, King Hussein Cancer Center, NYU Langone Health, Centre hospitalier de l'Université de Montréal (CHUM), Peter MacCallum Cancer Centre, Australia, CHU de Quebec-Universite Laval, Tel-Aviv Sourasky Medical Center, Virginia Commonwealth University, AOU Careggi, McGill University Health Centre/Research Institute of the McGill University Health Centre, Maisonneuve-Rosemont Hospital, Columbia University, Lakeridge Health, London Health Sciences Centre, Clínica IRAM, University of Malaya, Aga Khan University
- Responsible party
- Sponsor
- Investigators
- Danielle Rodin, MD, Principal investigator, Princess Margaret Cancer CentreAnne Koch, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592938
- Sponsor's protocol ID
- 22-5074
- Acronym
- PRESERVE
- Status last verified
- Jul 2026
- First submitted
- 14 Oct 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1.
PubMed 33812473Fingeret MC, Nipomnick S, Guindani M, Baumann D, Hanasono M, Crosby M. Body image screening for cancer patients undergoing reconstructive surgery. Psychooncology. 2014 Aug;23(8):898-905. doi: 10.1002/pon.3491. Epub 2014 Feb 6.
PubMed 25066586Martei YM, Vanderpuye V, Jones BA. Fear of Mastectomy Associated with Delayed Breast Cancer Presentation Among Ghanaian Women. Oncologist. 2018 Dec;23(12):1446-1452. doi: 10.1634/theoncologist.2017-0409. Epub 2018 Jun 29.
PubMed 29959283Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.
PubMed 31750868Korzets Y, Lee G, Espin-Garcia O, Purdie T, Koch AC, Hodgson D, Barry A, Fyles A. The Role of Partial Breast Radiation in the Previously Radiated Breast. Am J Clin Oncol. 2019 Dec;42(12):932-936. doi: 10.1097/COC.0000000000000584.
PubMed 31436745Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
PubMed 32663119Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.
PubMed 32580883Barrios CH, Reinert T, Werutsky G. Global Breast Cancer Research: Moving Forward. Am Soc Clin Oncol Educ Book. 2018 May 23;38:441-450. doi: 10.1200/EDBK_209183.
PubMed 30231347Abdel-Razeq H, Mansour A, Jaddan D. Breast Cancer Care in Jordan. JCO Glob Oncol. 2020 Feb;6:260-268. doi: 10.1200/JGO.19.00279.
PubMed 32083950Khader J, Glicksman RM, Mheid S, Mansour A, Giuliani ME, Gospodarowicz M, Almousa A, Abdel-Razeq H, Rodin D. Enhancing International Cancer Organization Collaborations: King Hussein Cancer Center and Princess Margaret Cancer Centre Model for Collaboration. J Cancer Educ. 2022 Jun;37(3):763-769. doi: 10.1007/s13187-020-01878-z. Epub 2020 Sep 14.
PubMed 32926325Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14.
PubMed 33453312
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)
- ClinicalTrials.gov ID
- NCT05592938
- Acronym / sponsor ID
- PRESERVE / 22-5074
- Conditions
- Breast Cancer, Breast Cancer Recurrent
- Keywords
- Hypofractionated
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Royal Victoria Regional Health Centre, AC Camargo Cancer Center, King Hussein Cancer Center, NYU Langone Health, Centre hospitalier de l'Université de Montréal (CHUM), Peter MacCallum Cancer Centre, Australia, CHU de Quebec-Universite Laval, Tel-Aviv Sourasky Medical Center, Virginia Commonwealth University, AOU Careggi, McGill University Health Centre/Research Institute of the McGill University Health Centre, Maisonneuve-Rosemont Hospital, Columbia University, Lakeridge Health, London Health Sciences Centre, Clínica IRAM, University of Malaya, Aga Khan University
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 27 Jun 2027 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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 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).
The target population for this study is women with localized 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rPBI | Experimental | Radiation: rPBI26Gy in 5 daily fractions over 1-week |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
- Tumour histology limited to lobular carcinoma only
- T4 disease
- Node positive or distant metastatic disease
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rPBIExternal beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week | Radiation | rPBI |
Primary outcome
Grade ≥3 toxicity associated with treatment
Time frame: During accrual period, up to 3 years
TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
15 secondary outcomes
Frequency radiation-associated toxicity (acute)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (acute)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Frequency radiation-associated toxicity (late)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Percentage radiation-associated toxicity (late)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence (invasive and DCIS)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of distant recurrence (invasive and DCIS)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (frequency)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (in-field) (percentage)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (frequency)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Location of local recurrence (out-of-field) (percentage)
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Risk of local recurrence after rPBI requiring mastectomy
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Invasive breast cancer free survival
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Overall survival
Time frame: 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI
Satisfaction with breasts
Time frame: Baseline, 1 year, 3 years, and 5 years post rPBI
Financial toxicity associated with treatment
Time frame: Baseline, 3 months, 1 year, and 3 years post rPBI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 33812473Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1.
- Background: PubMed 25066586Fingeret MC, Nipomnick S, Guindani M, Baumann D, Hanasono M, Crosby M. Body image screening for cancer patients undergoing reconstructive surgery. Psychooncology. 2014 Aug;23(8):898-905. doi: 10.1002/pon.3491. Epub 2014 Feb 6.
- Background: PubMed 29959283Martei YM, Vanderpuye V, Jones BA. Fear of Mastectomy Associated with Delayed Breast Cancer Presentation Among Ghanaian Women. Oncologist. 2018 Dec;23(12):1446-1452. doi: 10.1634/theoncologist.2017-0409. Epub 2018 Jun 29.
- Background: PubMed 31750868Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.
- Background: PubMed 31436745Korzets Y, Lee G, Espin-Garcia O, Purdie T, Koch AC, Hodgson D, Barry A, Fyles A. The Role of Partial Breast Radiation in the Previously Radiated Breast. Am J Clin Oncol. 2019 Dec;42(12):932-936. doi: 10.1097/COC.0000000000000584.
- Background: PubMed 32663119Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
- Background: PubMed 32580883Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.
- Background: PubMed 30231347Barrios CH, Reinert T, Werutsky G. Global Breast Cancer Research: Moving Forward. Am Soc Clin Oncol Educ Book. 2018 May 23;38:441-450. doi: 10.1200/EDBK_209183.
- Background: PubMed 32083950Abdel-Razeq H, Mansour A, Jaddan D. Breast Cancer Care in Jordan. JCO Glob Oncol. 2020 Feb;6:260-268. doi: 10.1200/JGO.19.00279.
- Background: PubMed 32926325Khader J, Glicksman RM, Mheid S, Mansour A, Giuliani ME, Gospodarowicz M, Almousa A, Abdel-Razeq H, Rodin D. Enhancing International Cancer Organization Collaborations: King Hussein Cancer Center and Princess Margaret Cancer Centre Model for Collaboration. J Cancer Educ. 2022 Jun;37(3):763-769. doi: 10.1007/s13187-020-01878-z. Epub 2020 Sep 14.
- Background: PubMed 33453312Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle Rodin, MD principal investigator
Princess Margaret Cancer Centre
Anne Koch, MD principal investigator
Princess Margaret Cancer Centre
19 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPBI in people with Breast Cancer and Breast Cancer Recurrent, run by University Health Network, Toronto at 19 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, United States, Australia, Brazil, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Rodin, MD ((416) 946-6513, danielle.rodin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade ≥3 toxicity associated with treatment (time frame: During accrual period, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592938, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.