Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
NCT ID: NCT05592938
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
171 participants
INTERVENTIONAL
2023-06-27
2027-06-27
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rPBI
26Gy in 5 daily fractions over 1-week
rPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Interventions
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rPBI
External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumour histology limited to lobular carcinoma only
* Extensive intraductal component
* 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
* 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
18 Years
99 Years
FEMALE
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Royal Victoria Regional Health Centre
UNKNOWN
AC Camargo Cancer Center
OTHER
King Hussein Cancer Center
OTHER
Tata Memorial Hospital
OTHER_GOV
NYU Langone Health
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Peter MacCallum Cancer Centre, Australia
OTHER
CHU de Quebec-Universite Laval
OTHER
l'Hopital Maisonneuve-Rosemont
UNKNOWN
L'Institut de recherche du Centre universitaire de sante McGill
UNKNOWN
Florence University Hospital
UNKNOWN
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Virginia Commonwealth University
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Danielle Rodin, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Anne Koch, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Virgina Community University Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
A.C.Camargo Cancer Center
São Paulo, São Paulo, Brazil
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Verspeeten Family Cancer Centre
London, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU de Québec-Université Laval
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Tel-Aviv Sourasky Medical Centre
Tel Aviv, , Israel
Florence University Hospital
Florence, , Italy
King Hussein Cancer Centre
Amman, Jordan, Jordan
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
Loibl 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.
Fingeret 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.
Martei 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.
Arthur 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.
Korzets 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.
Brunt 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.
Murray 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.
Barrios 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.
Abdel-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.
Khader 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.
Rodin 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.
Other Identifiers
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22-5074
Identifier Type: -
Identifier Source: org_study_id
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